{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "204145", "product_res_number": "Z-0682-2024", "event_date_initiated": "2023-10-19", "event_date_posted": "2024-01-09", "recall_status": "Open, Classified", "res_event_number": "93355", "product_code": "JJE", "product_description": "ARCHITECT c4000 Processing Module REF:\n02P24-01\n02P24-02\n02P24-40\n01R24-56\n01R25-56\n\nThe Abbott ARCHITECT c4000 Processing Module is designed to perform automated\nchemistry tests, utilizing photometry and potentiometric technology.", "code_info": "List Number:\n02P24-01\nSerial Numbers / UDI Codes:\nC400911\t(01)00380740003746(21)C400911\nC402913\t(01)00380740003746(21)C402913\nC460004\t(01)00380740003746(21)C460004\nC460033\t(01)00380740003746(21)C460033\nC460055\t(01)00380740003746(21)C460055\nC460066\t(01)00380740003746(21)C460066\nC460082\t(01)00380740003746(21)C460082\nC460158\t(01)00380740003746(21)C460158\nC460200\t(01)00380740003746(21)C460200\nC460375\t(01)00380740003746(21)C460375\nC460385\t(01)00380740003746(21)C460385\nC460396\t(01)00380740003746(21)C460396\nC460397\t(01)00380740003746(21)C460397\nC460408\t(01)00380740003746(21)C460408\nC460410\t(01)00380740003746(21)C460410\nC460422\t(01)00380740003746(21)C460422\nC460435\t(01)00380740003746(21)C460435\nC460439\t(01)00380740003746(21)C460439\nC460523\t(01)00380740003746(21)C460523\nC460532\t(01)00380740003746(21)C460532\nC460588\t(01)00380740003746(21)C460588\nC460728\t(01)00380740003746(21)C460728\nC460767\t(01)00380740003746(21)C460767\nC460797\t(01)00380740003746(21)C460797\nC460798\t(01)00380740003746(21)C460798\nC460800\t(01)00380740003746(21)C460800\nC460826\t(01)00380740003746(21)C460826\nC460827\t(01)00380740003746(21)C460827\nC460830\t(01)00380740003746(21)C460830\nC460832\t(01)00380740003746(21)C460832\nC460833\t(01)00380740003746(21)C460833\nC460834\t(01)00380740003746(21)C460834\nC460846\t(01)00380740003746(21)C460846\nC460849\t(01)00380740003746(21)C460849\nC460857\t(01)00380740003746(21)C460857\nC460868\t(01)00380740003746(21)C460868\nC460875\t(01)00380740003746(21)C460875\nC460886\t(01)00380740003746(21)C460886\nC460927\t(01)00380740003746(21)C460927\nC460928\t(01)00380740003746(21)C460928\nC460939\t(01)00380740003746(21)C460939\nC460958\t(01)00380740003746(21)C460958\nC460993\t(01)00380740003746(21)C460993\nC461042\t(01)00380740003746(21)C461042\nC461092\t(01)00380740003746(21)C461092\nC461093\t(01)00380740003746(21)C461093\nC461100\t(01)00380740003746(21)C461100\nC461105\t(01)00380740003746(21)C461105\nC461112\t(01)00380740003746(21)C461112\nC461122\t(01)00380740003746(21)C461122\nC461124\t(01)00380740003746(21)C461124\nC461129\t(01)00380740003746(21)C461129\nC461130\t(01)00380740003746(21)C461130\nC461132\t(01)00380740003746(21)C461132\nC461133\t(01)00380740003746(21)C461133\nC461138\t(01)00380740003746(21)C461138\nC461148\t(01)00380740003746(21)C461148\nC461150\t(01)00380740003746(21)C461150\nC461151\t(01)00380740003746(21)C461151\nC461155\t(01)00380740003746(21)C461155\nC461172\t(01)00380740003746(21)C461172\nC461173\t(01)00380740003746(21)C461173\nC461175\t(01)00380740003746(21)C461175\nC461176\t(01)00380740003746(21)C461176\nC461192\t(01)00380740003746(21)C461192\nC461195\t(01)00380740003746(21)C461195\nC461208\t(01)00380740003746(21)C461208\nC461212\t(01)00380740003746(21)C461212\nC461220\t(01)00380740003746(21)C461220\nC461222\t(01)00380740003746(21)C461222\nC461247\t(01)00380740003746(21)C461247\nC461250\t(01)00380740003746(21)C461250\nC461271\t(01)00380740003746(21)C461271\nC461272\t(01)00380740003746(21)C461272\nC461408\t(01)00380740003746(21)C461408\nC461412\t(01)00380740003746(21)C461412\nC461413\t(01)00380740003746(21)C461413\nC461414\t(01)00380740003746(21)C461414\nC461420\t(01)00380740003746(21)C461420\nC461425\t(01)00380740003746(21)C461425\nC461446\t(01)00380740003746(21)C461446\nC461451\t(01)00380740003746(21)C461451\nC461453\t(01)00380740003746(21)C461453\nC461455\t(01)00380740003746(21)C461455\nC461457\t(01)00380740003746(21)C461457\nC461459\t(01)00380740003746(21)C461459\nC461462\t(01)00380740003746(21)C461462\nC461473\t(01)00380740003746(21)C461473\nC461474\t(01)00380740003746(21)C461474\nC461475\t(01)00380740003746(21)C461475\nC461476\t(01)00380740003746(21)C461476\nC461477\t(01)00380740003746(21)C461477\nC461491\t(01)00380740003746(21)C461491\nC461492\t(01)00380740003746(21)C461492\nC461495\t(01)00380740003746(21)C461495\nC461496\t(01)00380740003746(21)C461496\nC461497\t(01)00380740003746(21)C461497\nC461498\t(01)00380740003746(21)C461498\nC461528\t(01)00380740003746(21)C461528\nC461553\t(01)00380740003746(21)C461553\nC461554\t(01)00380740003746(21)C461554\nC461555\t(01)00380740003746(21)C461555\nC461562\t(01)00380740003746(21)C461562\nC461563\t(01)00380740003746(21)C461563\nC461587\t(01)00380740003746(21)C461587\nC461597\t(01)00380740003746(21)C461597\nC461598\t(01)00380740003746(21)C461598\nC461621\t(01)00380740003746(21)C461621\nC461656\t(01)00380740003746(21)C461656\nC461658\t(01)00380740003746(21)C461658\nC461659\t(01)00380740003746(21)C461659\nC461660\t(01)00380740003746(21)C461660\nC461662\t(01)00380740003746(21)C461662\nC461663\t(01)00380740003746(21)C461663\nC461664\t(01)00380740003746(21)C461664\nC461667\t(01)00380740003746(21)C461667\nC461668\t(01)00380740003746(21)C461668\nC461674\t(01)00380740003746(21)C461674\nC461675\t(01)00380740003746(21)C461675\nC461676\t(01)00380740003746(21)C461676\nC461678\t(01)00380740003746(21)C461678\nC461680\t(01)00380740003746(21)C461680\nC461683\t(01)00380740003746(21)C461683\nC461684\t(01)00380740003746(21)C461684\nC461712\t(01)00380740003746(21)C461712\nC461713\t(01)00380740003746(21)C461713\nC461714\t(01)00380740003746(21)C461714\nC461716\t(01)00380740003746(21)C461716\nC461717\t(01)00380740003746(21)C461717\nC461720\t(01)00380740003746(21)C461720\nC461721\t(01)00380740003746(21)C461721\nC461723\t(01)00380740003746(21)C461723\nC461724\t(01)00380740003746(21)C461724\nC461751\t(01)00380740003746(21)C461751\nC461752\t(01)00380740003746(21)C461752\nC461770\t(01)00380740003746(21)C461770\nC461771\t(01)00380740003746(21)C461771\nC461772\t(01)00380740003746(21)C461772\nC461781\t(01)00380740003746(21)C461781\nC461782\t(01)00380740003746(21)C461782\nC461783\t(01)00380740003746(21)C461783\nC461800\t(01)00380740003746(21)C461800\nC461801\t(01)00380740003746(21)C461801\nC461802\t(01)00380740003746(21)C461802\nC461804\t(01)00380740003746(21)C461804\nC461820\t(01)00380740003746(21)C461820\nC461822\t(01)00380740003746(21)C461822\nC461823\t(01)00380740003746(21)C461823\nC461835\t(01)00380740003746(21)C461835\nC461837\t(01)00380740003746(21)C461837\nC461839\t(01)00380740003746(21)C461839\nC461840\t(01)00380740003746(21)C461840\nC461843\t(01)00380740003746(21)C461843\nC461846\t(01)00380740003746(21)C461846\nC461847\t(01)00380740003746(21)C461847\nC461848\t(01)00380740003746(21)C461848\nC461855\t(01)00380740003746(21)C461855\nC461856\t(01)00380740003746(21)C461856\nC461857\t(01)00380740003746(21)C461857\nC461873\t(01)00380740003746(21)C461873\nC461875\t(01)00380740003746(21)C461875\nC461881\t(01)00380740003746(21)C461881\nC461894\t(01)00380740003746(21)C461894\nC461895\t(01)00380740003746(21)C461895\nC461906\t(01)00380740003746(21)C461906\nC461919\t(01)00380740003746(21)C461919\nC461924\t(01)00380740003746(21)C461924\nC461931\t(01)00380740003746(21)C461931\nC461932\t(01)00380740003746(21)C461932\nC461934\t(01)00380740003746(21)C461934\nC461958\t(01)00380740003746(21)C461958\nC462013\t(01)00380740003746(21)C462013\nC462014\t(01)00380740003746(21)C462014\nC462015\t(01)00380740003746(21)C462015\nC462070\t(01)00380740003746(21)C462070\nC462081\t(01)00380740003746(21)C462081\nC462100\t(01)00380740003746(21)C462100\nC462108\t(01)00380740003746(21)C462108\nC462109\t(01)00380740003746(21)C462109\nC462116\t(01)00380740003746(21)C462116\nC462117\t(01)00380740003746(21)C462117\nC462123\t(01)00380740003746(21)C462123\nC462134\t(01)00380740003746(21)C462134\nC462135\t(01)00380740003746(21)C462135\nC462139\t(01)00380740003746(21)C462139\nC462144\t(01)00380740003746(21)C462144\nC462154\t(01)00380740003746(21)C462154\nC462156\t(01)00380740003746(21)C462156\nC462215\t(01)00380740003746(21)C462215\nC462216\t(01)00380740003746(21)C462216\nC462217\t(01)00380740003746(21)C462217\nC462218\t(01)00380740003746(21)C462218\nC462219\t(01)00380740003746(21)C462219\nC462220\t(01)00380740003746(21)C462220\nC462222\t(01)00380740003746(21)C462222\nC462234\t(01)00380740003746(21)C462234\nC462236\t(01)00380740003746(21)C462236\nC462239\t(01)00380740003746(21)C462239\nC462240\t(01)00380740003746(21)C462240\nC462241\t(01)00380740003746(21)C462241\nC462245\t(01)00380740003746(21)C462245\nC462246\t(01)00380740003746(21)C462246\nC462247\t(01)00380740003746(21)C462247\nC462249\t(01)00380740003746(21)C462249\nC462250\t(01)00380740003746(21)C462250\nC462254\t(01)00380740003746(21)C462254\nC462255\t(01)00380740003746(21)C462255\nC462256\t(01)00380740003746(21)C462256\nC462257\t(01)00380740003746(21)C462257\nC462309\t(01)00380740003746(21)C462309\nC462312\t(01)00380740003746(21)C462312\nC462313\t(01)00380740003746(21)C462313\nC462347\t(01)00380740003746(21)C462347\nC462384\t(01)00380740003746(21)C462384\nC462386\t(01)00380740003746(21)C462386\nC462402\t(01)00380740003746(21)C462402\nC462403\t(01)00380740003746(21)C462403\nC462404\t(01)00380740003746(21)C462404\nC462434\t(01)00380740003746(21)C462434\nC462436\t(01)00380740003746(21)C462436\nC462437\t(01)00380740003746(21)C462437\nC462439\t(01)00380740003746(21)C462439\nC462441\t(01)00380740003746(21)C462441\nC462446\t(01)00380740003746(21)C462446\nC462450\t(01)00380740003746(21)C462450\nC462506\t(01)00380740003746(21)C462506\nC462536\t(01)00380740003746(21)C462536\n\n02P24-02\nSerial Numbers / UDI codes:\nC460391\t(01)00380740081225(21)C460391\nC460394\t(01)00380740081225(21)C460394\nC460395\t(01)00380740081225(21)C460395\nC460430\t(01)00380740081225(21)C460430\nC460434\t(01)00380740081225(21)C460434\nC461123\t(01)00380740081225(21)C461123\n\n02P24-40\nSerial Numbers / UDI codes:\nC400062\t(01)00380740003753(21)C400062\nC400251\t(01)00380740003753(21)C400251\nC400268\t(01)00380740003753(21)C400268\nC400288\t(01)00380740003753(21)C400288\nC400350\t(01)00380740003753(21)C400350\nC400392\t(01)00380740003753(21)C400392\nC400399\t(01)00380740003753(21)C400399\nC400404\t(01)00380740003753(21)C400404\nC400412\t(01)00380740003753(21)C400412\nC400416\t(01)00380740003753(21)C400416\nC400430\t(01)00380740003753(21)C400430\nC400431\t(01)00380740003753(21)C400431\nC400445\t(01)00380740003753(21)C400445\nC400479\t(01)00380740003753(21)C400479\nC400491\t(01)00380740003753(21)C400491\nC400500\t(01)00380740003753(21)C400500\nC400515\t(01)00380740003753(21)C400515\nC400552\t(01)00380740003753(21)C400552\nC400561\t(01)00380740003753(21)C400561\nC400578\t(01)00380740003753(21)C400578\nC400624\t(01)00380740003753(21)C400624\nC400660\t(01)00380740003753(21)C400660\nC400668\t(01)00380740003753(21)C400668\nC400673\t(01)00380740003753(21)C400673\nC400680\t(01)00380740003753(21)C400680\nC400686\t(01)00380740003753(21)C400686\nC400689\t(01)00380740003753(21)C400689\nC400709\t(01)00380740003753(21)C400709\nC400710\t(01)00380740003753(21)C400710\nC400716\t(01)00380740003753(21)C400716\nC400725\t(01)00380740003753(21)C400725\nC400727\t(01)00380740003753(21)C400727\nC400741\t(01)00380740003753(21)C400741\nC400749\t(01)00380740003753(21)C400749\nC400750\t(01)00380740003753(21)C400750\nC400756\t(01)00380740003753(21)C400756\nC400757\t(01)00380740003753(21)C400757\nC400760\t(01)00380740003753(21)C400760\nC400761\t(01)00380740003753(21)C400761\nC400799\t(01)00380740003753(21)C400799\nC400804\t(01)00380740003753(21)C400804\nC400809\t(01)00380740003753(21)C400809\nC400811\t(01)00380740003753(21)C400811\nC400812\t(01)00380740003753(21)C400812\nC400816\t(01)00380740003753(21)C400816\nC400818\t(01)00380740003753(21)C400818\nC400836\t(01)00380740003753(21)C400836\nC400839\t(01)00380740003753(21)C400839\nC400842\t(01)00380740003753(21)C400842\nC400844\t(01)00380740003753(21)C400844\nC400847\t(01)00380740003753(21)C400847\nC400848\t(01)00380740003753(21)C400848\nC400857\t(01)00380740003753(21)C400857\nC400861\t(01)00380740003753(21)C400861\nC400870\t(01)00380740003753(21)C400870\nC400881\t(01)00380740003753(21)C400881\nC400884\t(01)00380740003753(21)C400884\nC400890\t(01)00380740003753(21)C400890\nC400927\t(01)00380740003753(21)C400927\nC400948\t(01)00380740003753(21)C400948\nC400993\t(01)00380740003753(21)C400993\nC400994\t(01)00380740003753(21)C400994\nC401003\t(01)00380740003753(21)C401003\nC401008\t(01)00380740003753(21)C401008\nC401010\t(01)00380740003753(21)C401010\nC401025\t(01)00380740003753(21)C401025\nC401027\t(01)00380740003753(21)C401027\nC401052\t(01)00380740003753(21)C401052\nC401080\t(01)00380740003753(21)C401080\nC401082\t(01)00380740003753(21)C401082\nC401083\t(01)00380740003753(21)C401083\nC401113\t(01)00380740003753(21)C401113\nC401119\t(01)00380740003753(21)C401119\nC401131\t(01)00380740003753(21)C401131\nC401149\t(01)00380740003753(21)C401149\nC401161\t(01)00380740003753(21)C401161\nC401180\t(01)00380740003753(21)C401180\nC401181\t(01)00380740003753(21)C401181\nC401182\t(01)00380740003753(21)C401182\nC401188\t(01)00380740003753(21)C401188\nC401189\t(01)00380740003753(21)C401189\nC401199\t(01)00380740003753(21)C401199\nC401204\t(01)00380740003753(21)C401204\nC401212\t(01)00380740003753(21)C401212\nC401213\t(01)00380740003753(21)C401213\nC401214\t(01)00380740003753(21)C401214\nC401217\t(01)00380740003753(21)C401217\nC401219\t(01)00380740003753(21)C401219\nC401231\t(01)00380740003753(21)C401231\nC401233\t(01)00380740003753(21)C401233\nC401234\t(01)00380740003753(21)C401234\nC401237\t(01)00380740003753(21)C401237\nC401251\t(01)00380740003753(21)C401251\nC401252\t(01)00380740003753(21)C401252\nC401253\t(01)00380740003753(21)C401253\nC401257\t(01)00380740003753(21)C401257\nC401263\t(01)00380740003753(21)C401263\nC401264\t(01)00380740003753(21)C401264\nC401265\t(01)00380740003753(21)C401265\nC401275\t(01)00380740003753(21)C401275\nC401282\t(01)00380740003753(21)C401282\nC401283\t(01)00380740003753(21)C401283\nC401284\t(01)00380740003753(21)C401284\nC401289\t(01)00380740003753(21)C401289\nC401294\t(01)00380740003753(21)C401294\nC401295\t(01)00380740003753(21)C401295\nC401301\t(01)00380740003753(21)C401301\nC401321\t(01)00380740003753(21)C401321\nC401341\t(01)00380740003753(21)C401341\nC401364\t(01)00380740003753(21)C401364\nC401367\t(01)00380740003753(21)C401367\nC401368\t(01)00380740003753(21)C401368\nC401369\t(01)00380740003753(21)C401369\nC401372\t(01)00380740003753(21)C401372\nC401373\t(01)00380740003753(21)C401373\nC401387\t(01)00380740003753(21)C401387\nC401388\t(01)00380740003753(21)C401388\nC401397\t(01)00380740003753(21)C401397\nC401399\t(01)00380740003753(21)C401399\nC401405\t(01)00380740003753(21)C401405\nC401406\t(01)00380740003753(21)C401406\nC401408\t(01)00380740003753(21)C401408\nC401409\t(01)00380740003753(21)C401409\nC401416\t(01)00380740003753(21)C401416\nC401417\t(01)00380740003753(21)C401417\nC401424\t(01)00380740003753(21)C401424\nC401425\t(01)00380740003753(21)C401425\nC401435\t(01)00380740003753(21)C401435\nC401452\t(01)00380740003753(21)C401452\nC401453\t(01)00380740003753(21)C401453\nC401456\t(01)00380740003753(21)C401456\nC401463\t(01)00380740003753(21)C401463\nC401468\t(01)00380740003753(21)C401468\nC401470\t(01)00380740003753(21)C401470\nC401484\t(01)00380740003753(21)C401484\nC401485\t(01)00380740003753(21)C401485\nC401486\t(01)00380740003753(21)C401486\nC401487\t(01)00380740003753(21)C401487\nC401488\t(01)00380740003753(21)C401488\nC401490\t(01)00380740003753(21)C401490\nC401492\t(01)00380740003753(21)C401492\nC401513\t(01)00380740003753(21)C401513\nC401517\t(01)00380740003753(21)C401517\nC401520\t(01)00380740003753(21)C401520\nC401522\t(01)00380740003753(21)C401522\nC401524\t(01)00380740003753(21)C401524\nC401532\t(01)00380740003753(21)C401532\nC401537\t(01)00380740003753(21)C401537\nC401538\t(01)00380740003753(21)C401538\nC401540\t(01)00380740003753(21)C401540\nC401543\t(01)00380740003753(21)C401543\nC401546\t(01)00380740003753(21)C401546\nC401548\t(01)00380740003753(21)C401548\nC401551\t(01)00380740003753(21)C401551\nC401552\t(01)00380740003753(21)C401552\nC401553\t(01)00380740003753(21)C401553\nC401555\t(01)00380740003753(21)C401555\nC401557\t(01)00380740003753(21)C401557\nC401558\t(01)00380740003753(21)C401558\nC401565\t(01)00380740003753(21)C401565\nC401568\t(01)00380740003753(21)C401568\nC401574\t(01)00380740003753(21)C401574\nC401575\t(01)00380740003753(21)C401575\nC401578\t(01)00380740003753(21)C401578\nC401585\t(01)00380740003753(21)C401585\nC401590\t(01)00380740003753(21)C401590\nC401599\t(01)00380740003753(21)C401599\nC401604\t(01)00380740003753(21)C401604\nC401617\t(01)00380740003753(21)C401617\nC401620\t(01)00380740003753(21)C401620\nC401624\t(01)00380740003753(21)C401624\nC401626\t(01)00380740003753(21)C401626\nC401635\t(01)00380740003753(21)C401635\nC401636\t(01)00380740003753(21)C401636\nC401639\t(01)00380740003753(21)C401639\nC401641\t(01)00380740003753(21)C401641\nC401642\t(01)00380740003753(21)C401642\nC401645\t(01)00380740003753(21)C401645\nC401648\t(01)00380740003753(21)C401648\nC401649\t(01)00380740003753(21)C401649\nC401653\t(01)00380740003753(21)C401653\nC401664\t(01)00380740003753(21)C401664\nC401666\t(01)00380740003753(21)C401666\nC401672\t(01)00380740003753(21)C401672\nC401674\t(01)00380740003753(21)C401674\nC401682\t(01)00380740003753(21)C401682\nC401683\t(01)00380740003753(21)C401683\nC401684\t(01)00380740003753(21)C401684\nC401685\t(01)00380740003753(21)C401685\nC401687\t(01)00380740003753(21)C401687\nC401689\t(01)00380740003753(21)C401689\nC401691\t(01)00380740003753(21)C401691\nC401693\t(01)00380740003753(21)C401693\nC401697\t(01)00380740003753(21)C401697\nC401698\t(01)00380740003753(21)C401698\nC401700\t(01)00380740003753(21)C401700\nC401703\t(01)00380740003753(21)C401703\nC401704\t(01)00380740003753(21)C401704\nC401705\t(01)00380740003753(21)C401705\nC401706\t(01)00380740003753(21)C401706\nC401708\t(01)00380740003753(21)C401708\nC401710\t(01)00380740003753(21)C401710\nC401711\t(01)00380740003753(21)C401711\nC401715\t(01)00380740003753(21)C401715\nC401716\t(01)00380740003753(21)C401716\nC401732\t(01)00380740003753(21)C401732\nC401733\t(01)00380740003753(21)C401733\nC401772\t(01)00380740003753(21)C401772\nC401773\t(01)00380740003753(21)C401773\nC401774\t(01)00380740003753(21)C401774\nC401783\t(01)00380740003753(21)C401783\nC401784\t(01)00380740003753(21)C401784\nC401793\t(01)00380740003753(21)C401793\nC401825\t(01)00380740003753(21)C401825\nC401826\t(01)00380740003753(21)C401826\nC401828\t(01)00380740003753(21)C401828\nC401838\t(01)00380740003753(21)C401838\nC401839\t(01)00380740003753(21)C401839\nC401849\t(01)00380740003753(21)C401849\nC401850\t(01)00380740003753(21)C401850\nC401855\t(01)00380740003753(21)C401855\nC401856\t(01)00380740003753(21)C401856\nC401857\t(01)00380740003753(21)C401857\nC401880\t(01)00380740003753(21)C401880\nC401881\t(01)00380740003753(21)C401881\nC401882\t(01)00380740003753(21)C401882\nC401885\t(01)00380740003753(21)C401885\nC401886\t(01)00380740003753(21)C401886\nC401887\t(01)00380740003753(21)C401887\nC401888\t(01)00380740003753(21)C401888\nC401889\t(01)00380740003753(21)C401889\nC401895\t(01)00380740003753(21)C401895\nC401897\t(01)00380740003753(21)C401897\nC401906\t(01)00380740003753(21)C401906\nC401946\t(01)00380740003753(21)C401946\nC401947\t(01)00380740003753(21)C401947\nC401949\t(01)00380740003753(21)C401949\nC401950\t(01)00380740003753(21)C401950\nC401951\t(01)00380740003753(21)C401951\nC401954\t(01)00380740003753(21)C401954\nC401955\t(01)00380740003753(21)C401955\nC401956\t(01)00380740003753(21)C401956\nC401957\t(01)00380740003753(21)C401957\nC401958\t(01)00380740003753(21)C401958\nC401959\t(01)00380740003753(21)C401959\nC401975\t(01)00380740003753(21)C401975\nC401976\t(01)00380740003753(21)C401976\nC401977\t(01)00380740003753(21)C401977\nC401978\t(01)00380740003753(21)C401978\nC401979\t(01)00380740003753(21)C401979\nC401986\t(01)00380740003753(21)C401986\nC401988\t(01)00380740003753(21)C401988\nC401989\t(01)00380740003753(21)C401989\nC401990\t(01)00380740003753(21)C401990\nC401993\t(01)00380740003753(21)C401993\nC401996\t(01)00380740003753(21)C401996\nC401997\t(01)00380740003753(21)C401997\nC401998\t(01)00380740003753(21)C401998\nC401999\t(01)00380740003753(21)C401999\nC402007\t(01)00380740003753(21)C402007\nC402008\t(01)00380740003753(21)C402008\nC402009\t(01)00380740003753(21)C402009\nC402011\t(01)00380740003753(21)C402011\nC402012\t(01)00380740003753(21)C402012\nC402013\t(01)00380740003753(21)C402013\nC402024\t(01)00380740003753(21)C402024\nC402025\t(01)00380740003753(21)C402025\nC402026\t(01)00380740003753(21)C402026\nC402027\t(01)00380740003753(21)C402027\nC402029\t(01)00380740003753(21)C402029\nC402036\t(01)00380740003753(21)C402036\nC402037\t(01)00380740003753(21)C402037\nC402038\t(01)00380740003753(21)C402038\nC402039\t(01)00380740003753(21)C402039\nC402040\t(01)00380740003753(21)C402040\nC402041\t(01)00380740003753(21)C402041\nC402042\t(01)00380740003753(21)C402042\nC402043\t(01)00380740003753(21)C402043\nC402044\t(01)00380740003753(21)C402044\nC402045\t(01)00380740003753(21)C402045\nC402046\t(01)00380740003753(21)C402046\nC402047\t(01)00380740003753(21)C402047\nC402048\t(01)00380740003753(21)C402048\nC402049\t(01)00380740003753(21)C402049\nC402050\t(01)00380740003753(21)C402050\nC402051\t(01)00380740003753(21)C402051\nC402052\t(01)00380740003753(21)C402052\nC402053\t(01)00380740003753(21)C402053\nC402054\t(01)00380740003753(21)C402054\nC402055\t(01)00380740003753(21)C402055\nC402056\t(01)00380740003753(21)C402056\nC402057\t(01)00380740003753(21)C402057\nC402058\t(01)00380740003753(21)C402058\nC402059\t(01)00380740003753(21)C402059\nC402060\t(01)00380740003753(21)C402060\nC402067\t(01)00380740003753(21)C402067\nC402068\t(01)00380740003753(21)C402068\nC402069\t(01)00380740003753(21)C402069\nC402070\t(01)00380740003753(21)C402070\nC402071\t(01)00380740003753(21)C402071\nC402072\t(01)00380740003753(21)C402072\nC402073\t(01)00380740003753(21)C402073\nC402074\t(01)00380740003753(21)C402074\nC402075\t(01)00380740003753(21)C402075\nC402076\t(01)00380740003753(21)C402076\nC402079\t(01)00380740003753(21)C402079\nC402080\t(01)00380740003753(21)C402080\nC402081\t(01)00380740003753(21)C402081\nC402083\t(01)00380740003753(21)C402083\nC402086\t(01)00380740003753(21)C402086\nC402087\t(01)00380740003753(21)C402087\nC402088\t(01)00380740003753(21)C402088\nC402106\t(01)00380740003753(21)C402106\nC402107\t(01)00380740003753(21)C402107\nC402110\t(01)00380740003753(21)C402110\nC402119\t(01)00380740003753(21)C402119\nC402124\t(01)00380740003753(21)C402124\nC402126\t(01)00380740003753(21)C402126\nC402148\t(01)00380740003753(21)C402148\nC402149\t(01)00380740003753(21)C402149\nC402150\t(01)00380740003753(21)C402150\nC402165\t(01)00380740003753(21)C402165\nC402166\t(01)00380740003753(21)C402166\nC402167\t(01)00380740003753(21)C402167\nC402168\t(01)00380740003753(21)C402168\nC402171\t(01)00380740003753(21)C402171\nC402172\t(01)00380740003753(21)C402172\nC402173\t(01)00380740003753(21)C402173\nC402182\t(01)00380740003753(21)C402182\nC402183\t(01)00380740003753(21)C402183\nC402184\t(01)00380740003753(21)C402184\nC402202\t(01)00380740003753(21)C402202\nC402203\t(01)00380740003753(21)C402203\nC402204\t(01)00380740003753(21)C402204\nC402206\t(01)00380740003753(21)C402206\nC402210\t(01)00380740003753(21)C402210\nC402233\t(01)00380740003753(21)C402233\nC402234\t(01)00380740003753(21)C402234\nC402235\t(01)00380740003753(21)C402235\nC402236\t(01)00380740003753(21)C402236\nC402237\t(01)00380740003753(21)C402237\nC402238\t(01)00380740003753(21)C402238\nC402247\t(01)00380740003753(21)C402247\nC402248\t(01)00380740003753(21)C402248\nC402249\t(01)00380740003753(21)C402249\nC402251\t(01)00380740003753(21)C402251\nC402252\t(01)00380740003753(21)C402252\nC402253\t(01)00380740003753(21)C402253\nC402254\t(01)00380740003753(21)C402254\nC402256\t(01)00380740003753(21)C402256\nC402267\t(01)00380740003753(21)C402267\nC402268\t(01)00380740003753(21)C402268\nC402280\t(01)00380740003753(21)C402280\nC402281\t(01)00380740003753(21)C402281\nC402282\t(01)00380740003753(21)C402282\nC402284\t(01)00380740003753(21)C402284\nC402285\t(01)00380740003753(21)C402285\nC402286\t(01)00380740003753(21)C402286\nC402287\t(01)00380740003753(21)C402287\nC402288\t(01)00380740003753(21)C402288\nC402289\t(01)00380740003753(21)C402289\nC402290\t(01)00380740003753(21)C402290\nC402291\t(01)00380740003753(21)C402291\nC402292\t(01)00380740003753(21)C402292\nC402296\t(01)00380740003753(21)C402296\nC402297\t(01)00380740003753(21)C402297\nC402298\t(01)00380740003753(21)C402298\nC402299\t(01)00380740003753(21)C402299\nC402301\t(01)00380740003753(21)C402301\nC402302\t(01)00380740003753(21)C402302\nC402304\t(01)00380740003753(21)C402304\nC402305\t(01)00380740003753(21)C402305\nC402306\t(01)00380740003753(21)C402306\nC402307\t(01)00380740003753(21)C402307\nC402308\t(01)00380740003753(21)C402308\nC402311\t(01)00380740003753(21)C402311\nC402326\t(01)00380740003753(21)C402326\nC402327\t(01)00380740003753(21)C402327\nC402331\t(01)00380740003753(21)C402331\nC402332\t(01)00380740003753(21)C402332\nC402333\t(01)00380740003753(21)C402333\nC402335\t(01)00380740003753(21)C402335\nC402336\t(01)00380740003753(21)C402336\nC402337\t(01)00380740003753(21)C402337\nC402338\t(01)00380740003753(21)C402338\nC402339\t(01)00380740003753(21)C402339\nC402346\t(01)00380740003753(21)C402346\nC402348\t(01)00380740003753(21)C402348\nC402349\t(01)00380740003753(21)C402349\nC402350\t(01)00380740003753(21)C402350\nC402354\t(01)00380740003753(21)C402354\nC402355\t(01)00380740003753(21)C402355\nC402356\t(01)00380740003753(21)C402356\nC402357\t(01)00380740003753(21)C402357\nC402358\t(01)00380740003753(21)C402358\nC402359\t(01)00380740003753(21)C402359\nC402361\t(01)00380740003753(21)C402361\nC402390\t(01)00380740003753(21)C402390\nC402391\t(01)00380740003753(21)C402391\nC402392\t(01)00380740003753(21)C402392\nC402393\t(01)00380740003753(21)C402393\nC402394\t(01)00380740003753(21)C402394\nC402395\t(01)00380740003753(21)C402395\nC402396\t(01)00380740003753(21)C402396\nC402397\t(01)00380740003753(21)C402397\nC402402\t(01)00380740003753(21)C402402\nC402403\t(01)00380740003753(21)C402403\nC402404\t(01)00380740003753(21)C402404\nC402405\t(01)00380740003753(21)C402405\nC402406\t(01)00380740003753(21)C402406\nC402407\t(01)00380740003753(21)C402407\nC402410\t(01)00380740003753(21)C402410\nC402411\t(01)00380740003753(21)C402411\nC402412\t(01)00380740003753(21)C402412\nC402413\t(01)00380740003753(21)C402413\nC402416\t(01)00380740003753(21)C402416\nC402417\t(01)00380740003753(21)C402417\nC402419\t(01)00380740003753(21)C402419\nC402422\t(01)00380740003753(21)C402422\nC402423\t(01)00380740003753(21)C402423\nC402424\t(01)00380740003753(21)C402424\nC402430\t(01)00380740003753(21)C402430\nC402431\t(01)00380740003753(21)C402431\nC402432\t(01)00380740003753(21)C402432\nC402434\t(01)00380740003753(21)C402434\nC402435\t(01)00380740003753(21)C402435\nC402436\t(01)00380740003753(21)C402436\nC402437\t(01)00380740003753(21)C402437\nC402438\t(01)00380740003753(21)C402438\nC402439\t(01)00380740003753(21)C402439\nC402440\t(01)00380740003753(21)C402440\nC402441\t(01)00380740003753(21)C402441\nC402455\t(01)00380740003753(21)C402455\nC402456\t(01)00380740003753(21)C402456\nC402457\t(01)00380740003753(21)C402457\nC402458\t(01)00380740003753(21)C402458\nC402459\t(01)00380740003753(21)C402459\nC402479\t(01)00380740003753(21)C402479\nC402480\t(01)00380740003753(21)C402480\nC402481\t(01)00380740003753(21)C402481\nC402483\t(01)00380740003753(21)C402483\nC402484\t(01)00380740003753(21)C402484\nC402485\t(01)00380740003753(21)C402485\nC402486\t(01)00380740003753(21)C402486\nC402487\t(01)00380740003753(21)C402487\nC402488\t(01)00380740003753(21)C402488\nC402490\t(01)00380740003753(21)C402490\nC402491\t(01)00380740003753(21)C402491\nC402492\t(01)00380740003753(21)C402492\nC402507\t(01)00380740003753(21)C402507\nC402508\t(01)00380740003753(21)C402508\nC402509\t(01)00380740003753(21)C402509\nC402510\t(01)00380740003753(21)C402510\nC402511\t(01)00380740003753(21)C402511\nC402512\t(01)00380740003753(21)C402512\nC402525\t(01)00380740003753(21)C402525\nC402527\t(01)00380740003753(21)C402527\nC402528\t(01)00380740003753(21)C402528\nC402531\t(01)00380740003753(21)C402531\nC402532\t(01)00380740003753(21)C402532\nC402533\t(01)00380740003753(21)C402533\nC402534\t(01)00380740003753(21)C402534\nC402536\t(01)00380740003753(21)C402536\nC402537\t(01)00380740003753(21)C402537\nC402538\t(01)00380740003753(21)C402538\nC402540\t(01)00380740003753(21)C402540\nC402559\t(01)00380740003753(21)C402559\nC402560\t(01)00380740003753(21)C402560\nC402562\t(01)00380740003753(21)C402562\nC402563\t(01)00380740003753(21)C402563\nC402564\t(01)00380740003753(21)C402564\nC402565\t(01)00380740003753(21)C402565\nC402567\t(01)00380740003753(21)C402567\nC402569\t(01)00380740003753(21)C402569\nC402575\t(01)00380740003753(21)C402575\nC402576\t(01)00380740003753(21)C402576\nC402577\t(01)00380740003753(21)C402577\nC402581\t(01)00380740003753(21)C402581\nC402589\t(01)00380740003753(21)C402589\nC402590\t(01)00380740003753(21)C402590\nC402592\t(01)00380740003753(21)C402592\nC402593\t(01)00380740003753(21)C402593\nC402594\t(01)00380740003753(21)C402594\nC402595\t(01)00380740003753(21)C402595\nC402596\t(01)00380740003753(21)C402596\nC402605\t(01)00380740003753(21)C402605\nC402607\t(01)00380740003753(21)C402607\nC402608\t(01)00380740003753(21)C402608\nC402611\t(01)00380740003753(21)C402611\nC402612\t(01)00380740003753(21)C402612\nC402613\t(01)00380740003753(21)C402613\nC402615\t(01)00380740003753(21)C402615\nC402616\t(01)00380740003753(21)C402616\nC402618\t(01)00380740003753(21)C402618\nC402622\t(01)00380740003753(21)C402622\nC402623\t(01)00380740003753(21)C402623\nC402624\t(01)00380740003753(21)C402624\nC402635\t(01)00380740003753(21)C402635\nC402638\t(01)00380740003753(21)C402638\nC402639\t(01)00380740003753(21)C402639\nC402642\t(01)00380740003753(21)C402642\nC402651\t(01)00380740003753(21)C402651\nC402658\t(01)00380740003753(21)C402658\nC402659\t(01)00380740003753(21)C402659\nC402660\t(01)00380740003753(21)C402660\nC402661\t(01)00380740003753(21)C402661\nC402662\t(01)00380740003753(21)C402662\nC402663\t(01)00380740003753(21)C402663\nC402665\t(01)00380740003753(21)C402665\nC402668\t(01)00380740003753(21)C402668\nC402669\t(01)00380740003753(21)C402669\nC402671\t(01)00380740003753(21)C402671\nC402672\t(01)00380740003753(21)C402672\nC402673\t(01)00380740003753(21)C402673\nC402674\t(01)00380740003753(21)C402674\nC402675\t(01)00380740003753(21)C402675\nC402692\t(01)00380740003753(21)C402692\nC402705\t(01)00380740003753(21)C402705\nC402707\t(01)00380740003753(21)C402707\nC402708\t(01)00380740003753(21)C402708\nC402709\t(01)00380740003753(21)C402709\nC402720\t(01)00380740003753(21)C402720\nC402721\t(01)00380740003753(21)C402721\nC402722\t(01)00380740003753(21)C402722\nC402739\t(01)00380740003753(21)C402739\nC402741\t(01)00380740003753(21)C402741\nC402754\t(01)00380740003753(21)C402754\nC402755\t(01)00380740003753(21)C402755\nC402756\t(01)00380740003753(21)C402756\nC402769\t(01)00380740003753(21)C402769\nC402770\t(01)00380740003753(21)C402770\nC402773\t(01)00380740003753(21)C402773\nC402774\t(01)00380740003753(21)C402774\nC402775\t(01)00380740003753(21)C402775\nC402776\t(01)00380740003753(21)C402776\nC402780\t(01)00380740003753(21)C402780\nC402781\t(01)00380740003753(21)C402781\nC402782\t(01)00380740003753(21)C402782\nC402784\t(01)00380740003753(21)C402784\nC402785\t(01)00380740003753(21)C402785\nC402786\t(01)00380740003753(21)C402786\nC402787\t(01)00380740003753(21)C402787\nC402788\t(01)00380740003753(21)C402788\nC402790\t(01)00380740003753(21)C402790\nC402791\t(01)00380740003753(21)C402791\nC402792\t(01)00380740003753(21)C402792\nC402793\t(01)00380740003753(21)C402793\nC402795\t(01)00380740003753(21)C402795\nC402796\t(01)00380740003753(21)C402796\nC402797\t(01)00380740003753(21)C402797\nC402806\t(01)00380740003753(21)C402806\nC402807\t(01)00380740003753(21)C402807\nC402808\t(01)00380740003753(21)C402808\nC402828\t(01)00380740003753(21)C402828\nC402829\t(01)00380740003753(21)C402829\nC402831\t(01)00380740003753(21)C402831\nC402834\t(01)00380740003753(21)C402834\nC402835\t(01)00380740003753(21)C402835\nC402836\t(01)00380740003753(21)C402836\nC402837\t(01)00380740003753(21)C402837\nC402838\t(01)00380740003753(21)C402838\nC402840\t(01)00380740003753(21)C402840\nC402845\t(01)00380740003753(21)C402845\nC402846\t(01)00380740003753(21)C402846\nC402848\t(01)00380740003753(21)C402848\nC402849\t(01)00380740003753(21)C402849\nC402850\t(01)00380740003753(21)C402850\nC402851\t(01)00380740003753(21)C402851\nC402852\t(01)00380740003753(21)C402852\nC402853\t(01)00380740003753(21)C402853\nC402854\t(01)00380740003753(21)C402854\nC402855\t(01)00380740003753(21)C402855\nC402856\t(01)00380740003753(21)C402856\nC402864\t(01)00380740003753(21)C402864\nC402865\t(01)00380740003753(21)C402865\nC402866\t(01)00380740003753(21)C402866\nC402867\t(01)00380740003753(21)C402867\nC402868\t(01)00380740003753(21)C402868\nC402895\t(01)00380740003753(21)C402895\nC402896\t(01)00380740003753(21)C402896\nC402898\t(01)00380740003753(21)C402898\nC402899\t(01)00380740003753(21)C402899\nC402900\t(01)00380740003753(21)C402900\nC402901\t(01)00380740003753(21)C402901\nC402902\t(01)00380740003753(21)C402902\nC402903\t(01)00380740003753(21)C402903\nC402904\t(01)00380740003753(21)C402904\nC402911\t(01)00380740003753(21)C402911\nC402912\t(01)00380740003753(21)C402912\nC402914\t(01)00380740003753(21)C402914\nC402938\t(01)00380740003753(21)C402938\nC402939\t(01)00380740003753(21)C402939\nC402940\t(01)00380740003753(21)C402940\nC402941\t(01)00380740003753(21)C402941\nC402953\t(01)00380740003753(21)C402953\nC402954\t(01)00380740003753(21)C402954\nC402955\t(01)00380740003753(21)C402955\nC402956\t(01)00380740003753(21)C402956\nC402958\t(01)00380740003753(21)C402958\nC402959\t(01)00380740003753(21)C402959\nC402960\t(01)00380740003753(21)C402960\nC402961\t(01)00380740003753(21)C402961\nC402962\t(01)00380740003753(21)C402962\nC402963\t(01)00380740003753(21)C402963\nC402982\t(01)00380740003753(21)C402982\nC402983\t(01)00380740003753(21)C402983\nC402985\t(01)00380740003753(21)C402985\nC402996\t(01)00380740003753(21)C402996\nC402997\t(01)00380740003753(21)C402997\nC402998\t(01)00380740003753(21)C402998\nC403006\t(01)00380740003753(21)C403006\nC403007\t(01)00380740003753(21)C403007\nC403008\t(01)00380740003753(21)C403008\nC403009\t(01)00380740003753(21)C403009\nC403018\t(01)00380740003753(21)C403018\nC403019\t(01)00380740003753(21)C403019\nC403025\t(01)00380740003753(21)C403025\nC403026\t(01)00380740003753(21)C403026\nC403027\t(01)00380740003753(21)C403027\nC403036\t(01)00380740003753(21)C403036\nC403060\t(01)00380740003753(21)C403060\nC403061\t(01)00380740003753(21)C403061\nC403062\t(01)00380740003753(21)C403062\nC403070\t(01)00380740003753(21)C403070\nC403071\t(01)00380740003753(21)C403071\nC403072\t(01)00380740003753(21)C403072\nC403073\t(01)00380740003753(21)C403073\nC403074\t(01)00380740003753(21)C403074\nC403075\t(01)00380740003753(21)C403075\nC403096\t(01)00380740003753(21)C403096\nC403128\t(01)00380740003753(21)C403128\nC403129\t(01)00380740003753(21)C403129\nC403130\t(01)00380740003753(21)C403130\nC403131\t(01)00380740003753(21)C403131\nC403132\t(01)00380740003753(21)C403132\nC403133\t(01)00380740003753(21)C403133\nC403154\t(01)00380740003753(21)C403154\nC403155\t(01)00380740003753(21)C403155\nC403156\t(01)00380740003753(21)C403156\nC403174\t(01)00380740003753(21)C403174\nC403178\t(01)00380740003753(21)C403178\nC403179\t(01)00380740003753(21)C403179\nC403180\t(01)00380740003753(21)C403180\nC403186\t(01)00380740003753(21)C403186\nC403187\t(01)00380740003753(21)C403187\nC403188\t(01)00380740003753(21)C403188\nC403191\t(01)00380740003753(21)C403191\nC403192\t(01)00380740003753(21)C403192\nC403193\t(01)00380740003753(21)C403193\nC403202\t(01)00380740003753(21)C403202\nC403203\t(01)00380740003753(21)C403203\nC403204\t(01)00380740003753(21)C403204\nC403214\t(01)00380740003753(21)C403214\nC403215\t(01)00380740003753(21)C403215\nC403220\t(01)00380740003753(21)C403220\nC403221\t(01)00380740003753(21)C403221\nC403224\t(01)00380740003753(21)C403224\nC403226\t(01)00380740003753(21)C403226\nC403227\t(01)00380740003753(21)C403227\nC403228\t(01)00380740003753(21)C403228\nC403262\t(01)00380740003753(21)C403262\nC403310\t(01)00380740003753(21)C403310\nC460089\t(01)00380740003753(21)C460089\nC460433\t(01)00380740003753(21)C460433\n\n01R24-56\n01R25-56\nSerial Numbers and UDI codes were not provided. These two products were only distributed O.U.S. (Brazil)", "firm_fei_number": "3016438761", "recalling_firm": "Abbott Laboratories", "address_1": "1915 Hurd Dr", "city": "Irving", "state": "TX", "postal_code": "75038-4313", "additional_info_contact": "Suchin Song\n224-668-0343", "reason_for_recall": "The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).", "root_cause_description": "Under Investigation by firm", "action": "On 10/19/2023, the firm sent an \"Urgent Medical Device Correction\" Letter via FedEx priority overnight express to customers informing them that Abbott has determined that, A labeling update is required for the products listed above to meet US regulatory requirement 21 CFR 801.437 (User labeling for devices that contain natural rubber) and Brazilian requirement RDC 37/2015 (medical devices and IVDs to include in the label a Standardized Latex Warning in Portuguese CONTAIN NATURAL LATEX. MAY CAUSE ALLERGIES ). These Abbott products include internal hardware parts and/or subassemblies that contain dry natural rubber (latex) which may cause allergic reactions, but do not include the required precautionary label. Additionally, the Alinity s System Solid Waste Container Rubber Band (LN 04U97-01), used to secure the biohazard bag to the solid waste container, contains dry natural rubber (latex).\n\nCustomer are instructed to:\n1) Follow good laboratory practice by wearing impervious gloves and other personal protective equipment when working on the above listed Abbott product(s).\n2) If you have forwarded the product(s) listed above to other laboratories, please inform them of this Product Correction and provide a copy of this letter.\n3) Please retain this letter for your laboratory records.\n\nA precautionary label will be applied to the affected products. An Abbott representative will schedule a service visit when the instrument label is available for application.\n\nFor questions or concerns, contact Customer Service at 1-877-4ABBOTT (24 hr/7 days a week).", "product_quantity": "995 systems", "distribution_pattern": "U.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV\n\nO.U.S.: Brazil", "openfda": { "k_number": [ "K965240", "K862235", "K872494", "K832584", "K003721", "K800572", "K823762", "K890927", "K051087", "K963539", "K961274", "K961142", "K841916", "K073370", "K833833", "K852133", "K823386", "K882307", "K840883", "K040958", "K974779", "K915106", "K864849", "K780464", "K833448", "K854138", "K771245", "K782014", "K834534", "K852262", "K883539", "K942443", "K873617", "K953239", "K802320", "K800085", "K890928", "K820888", "K855196", "K950915", "K063144", "K912844", "K822465", "K130915", "K820687", "K002982", "K790072", "K853391", "K853699", "K840129", "K885289", "K860021", "K962235", "K010500", "K861055", "K843283", "K813102", "K854025", "K810596", "K771345", "K800053", "K923579", "K962231", "K872302", "K983345", "K840868", "K830762", "K853621", "K872105", "K920402", "K840120", "K841503", "K903071", "K872103", "K883321", "K922072", "K830301", "K882913", "K131554", "K961481", "K901346", "K921661", "K882559", "K821335", "K893137", "K883209", "K791296", "K772344", "K183375", "K831518", "K813160", "K770679", "K851638", "K946090", "K890184", "K933703", "K894222", "K940289", "K833116", "K882194", "K874857", "K870836", "K831649", "K883533", "K772319", "K811919", "K781528", "K884378", "K974651", "K922680", "K944028", "K951189", "K831477", "K842500", "K881495", "K924084", "K885288", "K950353", "K844114", "K843059", "K780083", "K950958", "K942364", "K862818", "K860080", "K923060", "K882451", "K113253", "K810549", "K893776", "K873130", "K840501", "K133519", "K802609", "K945566", "K890929", "K885226", "K940810", "K901003", "K865105", "K803267", "K023764", "K830318", "K832115", "K933548", "K873749", "K945271", "K922139", "K834521", "K890183", "K870833", "K863531", "K904219", "K803135", "K893547", "K830212", "K884035", "K863840", "K854936", "K801889", "K781076", "K915366", "K971761", "K926060", "K760642", "K904220", "K130276", "K970227", "K912024", "K882081", "K860647", "K860748", "K843082", "K902336", "K110035", "K792361", "K112999", "K895423", "K922220", "K791297", "K853003", "K962125", "K841076", "K931786", "K882914", "K833067", "K882450", "K842773", "K820118", "K802835", "K042169", "K810129", "K942922", "K843610", "K854243", "K811194", "K881498", "K945135", "K931744", "K944093", "K902689", "K832648", "K910185", "K943493", "K872104", "K872813", "K780388", "K930489" ], "pma_number": [ "P910007" ], "registration_number": [ "", "2016473", "3029973107", "8030478", "3008494306", "3010031137", "3034707949", "3008244372", "3004378326", "1036362", "1424235", "3009238284", "9610126", "3002889627", "9610942", "1827821", "3000308930", "3042177088", "3003402518", "3008425728", "3003268355", "1181121", "3023268435", "1832216", "3003559191", "3002806944", "2026994", "8043379", "2517506", "3027977508", "9614673", "3003795116", "3005643513", "1319809", "3012471076", "3011061417", "1036223", "9610529", "1219913", "9613959", "9615056", "2915796", "3003593973", "1317202", "3011179004", "1219029", "2030861", "3005342322", "1931251", "1717966", "8020888", "2245578", "3007662974", "1000256526", "3008344661", "3004102403", "3017098905", "3042244350", "3035708936", "2050010", "9614373", "3008576040", "3017019647", "3021394862", "2122870", "3014840402", "3003741796", "1643621", "3016438761", "3014643041", "9610806", "3033967997", "3007361513", "9610240", "2435505", "3009156722", "3003637681", "3005529799", "3005748784", "3005509212", "3017548799", "9615037", "2032900", "2431530", "3006198300", "3037000637", "3003589956", "3007111389", "3012057020", "3007603826", "3005748564", "3009297077", "3005333358", "3014353045", "1319436", "3004973408", "3010610113", "3014325803", "3009473156", "3003917514", "3005094123", "3004434309", "3000148879", "3011989923", "3005622096", "2085064", "3003542872", "3016244760", "2432235", "8020316", "3030493719", "3002809144", "3020978007", "2027969", "2221819", "3014150341", "9612296", "3013660430", "3005655287", "9680746", "2050012", "2032839", "3014717638", "8021924", "8023060", "2247288", "9615837", "2523553", "9681753", "3012526002", "3008853996", "1616487", "2250051", "1000455123", "3009518015", "3006677029", "2020726", "3003030793", "1319808", "3004529019", "3002642396", "9614698", "3007135420", "9615754", "3006716639", "3004438098", "3007208259", "1220972", "3007500635", "3009984016", "3010825766", "1415939", "3042268054", "3015969360", "1319681", "3007118747", "3030234142", "3044473429", "3008517993", "3004145393", "3002895169", "3010324880", "3012963943", "8031673", "1217183", "3023162659", "2915274", "3004493545", "3009711478", "9610566", "3010421384", "3017894300", "3014607865", "2182595" ], "fei_number": [ "", "3029973107", "3008494306", "3010031137", "3003992026", "1000206808", "3034707949", "3008244372", "3004378326", "1036362", "3009238284", "3002889627", "1000120319", "1000305841", "1827821", "3000308930", "3042177088", "3003402518", "1000119795", "3008425728", "3003268355", "1181121", "3002485711", "3023268435", "1832216", "3003559191", "3004185580", "3002806944", "2026994", "3003413192", "2517506", "3027977508", "3003795116", "3005643513", "1000122044", "3012471076", "3011061417", "1036223", "1219913", "2915796", "3003593973", "1317202", "3011179004", "1219029", "3002806560", "3005342322", "3007019572", "1931251", "3003559576", "1717966", "2245578", "3007662974", "1000256526", "3008344661", "3004102403", "3017098905", "3003261083", "3042244350", "3035708936", "2050010", "3021394862", "3008576040", "3017019647", "2122870", "3014840402", "3002808212", "3002808340", "3003741796", "3004445302", "1643621", "1000305840", "3016438761", "3001075266", "3014643041", "1000135102", "3002807876", "3033967997", "3007361513", "1000186023", "1000136573", "3000215862", "3009156722", "3003637681", "3005529799", "3002808382", "3005748784", "3005509212", "3017548799", "3002806809", "2967", "2431530", "3006198300", "3037000637", "3002807663", "3003589956", "3007111389", "3012057020", "3007603826", "3005748564", "3009297077", "3005333358", "3014353045", "3004973408", "3010610113", "3014325803", "3009473156", "1000125787", "3003917514", "3005094123", "3004434309", "3000148879", "3011989923", "3005622096", "3003542872", "3016244760", "2432235", "3030493719", "2221819", "3002809144", "3020978007", "3014150341", "3013660430", "3005655287", "3001576181", "3002608770", "2050012", "3014717638", "3007262384", "2523553", "3012526002", "3008853996", "3002806559", "1616487", "2250051", "1000455123", "3009518015", "3006677029", "2020726", "3001644026", "3008237827", "3003030793", "3004529019", "3000303338", "3002642396", "3007135420", "3006716639", "3004438098", "3007208259", "1220972", "3007500635", "3009984016", "3010825766", "1415939", "3042268054", "3015969360", "3007118747", "3030234142", "3044473429", "3008517993", "3004145393", "1000125596", "3002895169", "3010324880", "3012963943", "1217183", "3002808301", "3023162659", "2915274", "3004493545", "3009711478", "3010421384", "3017894300", "3014607865", "2182595" ], "device_name": "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2160", "device_class": "1" } } ] }