{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194734", "product_res_number": "Z-1479-2022", "event_date_initiated": "2022-06-22", "event_date_created": "2022-07-28", "recall_status": "Open, Classified", "res_event_number": "90549", "product_code": "OOI", "k_numbers": [ "K170558" ], "product_description": "Revogene, Catalog no. 610210. IVD test instrument", "code_info": "UDI-DI: 00840733102318\nFirmware version V2.1.0\nSerial Numbers:\n231529\n231645\n231175\n231224\n231293\n231297\n231707\n231807\n231737\n231292\n231300\n231466\n231736\n231703\n231713\n231589\n231427\n231450\n231509\n231511\n231760\n231797\n231555\n231327\n231426\n231273\n231731\n231764\n231383\n231530\n231532\n231610\n231614\n231619\n231693\n231705\n231819\n231820\n231821\n231507\n231643\n231151\n231400\n231188\n231248\n231284\n231391\n231221\n231492\n231618\n231787\n231776\n231654\n231660\n231595\n231625\n231172\n231686\n231687\n231691\n231692\n231749\n231160\n231653\n231673\n231220\n231533\n231697\n231617\n231765\n231261\n231661\n231664\n231738\n231783\n231170\n231374\n231381\n231688\n231320\n231774\n231582\n231583\n231389\n231402\n231698\n231271\n231564\n231494\n231601\n231258\n231662\n231566\n231228\n231296\n231521\n231526\n231527\n231649\n231656\n231205\n231712\n231312\n231395\n231399\n231398\n231675\n231299\n231655\n231486\n231557\n231762\n231546\n231482\n231223\n231460\n231586\n231684\n231642\n231706\n231560\n231730\n231487\n231538\n231542\n231545\n231548\n231554\n231559\n231561\n231648\n231380\n231528\n231537\n231541\n231573\n231602\n231255\n231423\n231430\n231304\n231311\n231734\n231231\n231503\n231457\n231767\n231750\n231779\n231780\n231202\n231234\n231575\n231822\n231549\n231472\n231388\n231567\n231385\n231543\n231471\n231802\n231748\n231638\n231667\n231518\n231496\n231732\n231337\n231714\n231428\n231295\n231726\n231708\n231716\n231598\n231499\n231340\n231523\n231588\n231784\n231786\n231260\n231513\n231677\n231803\n231622\n231623\n231242\n231493\n231796\n231489\n231683\n231799\n231263\n231266\n231446\n231470\n231475\n231637\n231671\n231746\n231758\n231801\n231367\n231286\n231382\n231268\n231609\n231378\n231727\n231433\n231790\n231578\n231647\n231590\n231596\n231335\n231424\n231153\n231155\n231240\n231245\n231246\n231274\n231281\n231301\n231323\n231338\n231339\n231375\n231393\n231408\n231467\n231479\n231483\n231488\n231682\n231696\n231710\n231718\n231720\n231759\n231771\n231808\n231814\n231815\n231816\n231817\n231818\n231838\n231839\n231840\n231841\n231842\n231843\n231844\n231845\n231846\n231847\n231848\n231849\n231850\n231851\n231852\n231853\n231213\n231330\n231366\n231373\n231480\n231563\n231568\n231444\n231272\n231418\n231434\n231319\n231305\n231324\n231279\n231631\n231477\n231252\n231632\n231612\n231309\n231265\n231288\n231165\n231490\n231247\n231290\n231355\n231495\n231603\n231571\n231587\n231591\n231282\n231179\n231262\n231751\n231789\n231694\n231306\n231318\n231307\n231599\n231405\n231422\n231551\n231702\n231804\n231464\n231624\n231663\n231468\n231469\n231756\n231303\n231352\n231485\n231659\n231800\n231504\n231510\n231462\n231463\n231723\n231259\n231314\n231717\n231823\n231806\n231425\n231384\n231761\n231343\n231753\n231791\n231285\n231497\n231650\n231605\n231657\n231704\n231277\n231180\n231410\n231412\n231414\n231386\n231478\n231166\n231775\n231241\n231275\n231283\n231287\n231634\n231795\n231525\n231547\n231465\n231244\n231289\n231344\n231553\n231562\n231651\n231724\n231754\n231342\n231436\n231445\n231456\n231473\n231611\n231615\n231437\n231438\n231451\n231600\n231455\n231491\n231394\n231454\n231636\n231597\n231627\n231407\n231448\n231512\n231524\n231576\n231365\n231353\n231440\n231441\n231442\n231592\n231701\n231325\n231439\n231329\n231403\n231772\n231621\n231298\n231317\n231579\n231788\n231635\n231742\n231516\n231577\n231629\n231413\n231536\n231539\n231585\n231725\n231763\n231280\n231253\n231565\n231689\n231310\n231581\n231785\n231162\n231498\n231358\n231453\n231356\n231417\n231572\n231302\n231646\n231745\n231227\n231798\n231401\n231254\n231505\n231616\n231755\n231781\n231291\n231229\n231336\n231626\n231167\n231232\n231236\n231237\n231238\n231239", "firm_fei_number": "1524213", "recalling_firm": "Meridian Bioscience Inc", "address_1": "3471 River Hills Dr", "city": "Cincinnati", "state": "OH", "postal_code": "45244-3023", "additional_info_contact": "Ryan Spradling\n800-343-3858", "reason_for_recall": "When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury such as minor burns.", "root_cause_description": "Device Design", "action": "On June 22, 2022, the firm notified customers via email.\n\nCustomers were instructed that if a run is aborted and an error code presented, they SHOULD NOT open the instrument. DO NOT touch the retention ring or the inside of the lid as they may be hot. The firm recommends that customers wait approximately 10 minutes to allow the instrument to cool prior to opening the lid and removing the test devices.\n\nThe firm has developed a firmware solution to prevent the lid from being opened after an aborted run prior to the completion of the cooling period. The Meridian Bioscience Technical Services team will contact you to set up an appointment for firmware installation once available.", "product_quantity": "459 (394 US, 65 OUS)", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland.", "openfda": { "k_number": [ "K220480", "K140447", "K160517", "K102314", "K151690", "K161495", "K093383", "K170558", "K113319", "K151917", "K222779", "K243922", "K092705", "K123955" ], "registration_number": [ "3006198300", "3008517993", "3005748564", "3009984016", "3016619649", "3017644086", "3006028115", "3008318433", "3016635427", "3004530258", "3014325803", "2243471", "3005118020", "3007867838", "3014661462", "3022977716", "3026940910", "3003018722", "3003366417", "3012918440", "3043088937", "3009613136", "1528450", "3016548670", "3005248192", "3008754394", "3016838963", "3003673482", "3012449645", "3009875001", "3002777243", "3007420875", "3023999024", "3009297077", "3007923088", "3003540236", "3020925311", "3029059580", "3002773840", "3011461582", "3012259842", "3005748784", "3003537036", "3009609218", "3004061467", "2024674", "3004013603", "3003402518", "3012598266", "3027645317", "1524213", "9610240", "3011781554", "3009155756", "3004141078", "3042971506", "3003795116", "2024800", "3008494306", "1221359", "3003030793", "1550222", "9610126", "1650733", "2022994", "3023372670", "3007799234", "3009972873", "3024647994", "1119779", "3016837106", "3026886124", "3003083993", "3019837962", "3025430789", "3012494290", "3019946577", "8043379", "2023365", "3043138885" ], "fei_number": [ "3006198300", "3008517993", "3005748564", "3009984016", "3016619649", "1000122536", "3017644086", "3006028115", "3008318433", "3016635427", "3004530258", "3014325803", "3002524000", "2243471", "3014661462", "3022977716", "3026940910", "3003018722", "3003366417", "3012918440", "3043088937", "3003413192", "3009613136", "3016548670", "3005248192", "3008754394", "3016838963", "3003673482", "3012449645", "3009875001", "3002777243", "3009391812", "3007420875", "3023999024", "3009297077", "3007923088", "3003540236", "3020925311", "3029059580", "3002773840", "3011461582", "3012259842", "3005748784", "3003537036", "3009609218", "3004061467", "2024674", "3002808212", "3004013603", "3003402518", "3012598266", "3027645317", "1524213", "3011781554", "3009155756", "3004141078", "3042971506", "3002806559", "3003795116", "2024800", "3008494306", "1221359", "3003030793", "1550222", "2022994", "3023372670", "3007799234", "3009972873", "3024647994", "1119779", "3016837106", "3026886124", "3003083993", "3019837962", "1000161215", "3025430789", "3012494290", "3019946577", "2023365", "3043138885" ], "device_name": "Real Time Nucleic Acid Amplification System", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2570", "device_class": "2" } } ] }