{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "204926", "product_res_number": "Z-0782-2024", "event_date_initiated": "2023-12-15", "event_date_posted": "2024-01-23", "recall_status": "Open, Classified", "res_event_number": "93593", "product_code": "OOI", "product_description": "PANTHER FUSION System REF 9121010000\n\n\nThe Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is an integrated, fully automated, in vitro diagnostic (IVD) clinical multiplex test system. It is capable of performing nucleic acid based tests from sample processing through amplification, detection, and data reduction.", "code_info": "Fusion System Part Number: ASY-09600\nUDI Code: Pending\nSerial Numbers Panther / Fusion:\n1010910036\t2101000822\n1010910056\t2101000883\n1010910064\t2101000783\n1010910075\t2101000786\n1010910111\t2101000654\n1010910171\t2101000961\n1010910195\t2101000810\n1010910216\t2101000866\n1010910220\t2101000500\n1010910343\t2101000779\n1010910389\t2101000901\n1010910453\t2101000900\n1010910461\t2101000675\n1010910470\t2101000645\n1010910504\t2101000674\n1010910544\t2101000703\n1010910551\t2101001001\n1010910571\t2101000837\n1010910647\t2101000893\n1010910649\t2101000712\n1010910672\t2101000760\n1010910686\t2101000979\n1010910690\t2101000775\n1010910691\t2101000778\n1010910716\t2101000845\n1010910731\t2101000827\n1010910732\t2101000831\n1010910733\t2101000807\n1010910789\t2101000858\n1010910790\t2101000859\n1010910795\t2101000879\n1010910821\t2101000894\n1010910824\t2101000916\n1010910825\t2101000917\n1010910826\t2101000919\n1010910837\t2101000846\n1010910856\t2101000939\n1010910877\t2101000947\n2090000355\t2101000218\n2090000527\t2101000791\n2090000585\t2102100927\n2090000617\t2101000355\n2090000747\t2101000655\n2090000798\t2101000344\n2090000896\t2101000885\n2090000902\t2101000918\n2090000909\t2101000236\n2090000959\t2101000414\n2090000996\t2101000334\n2090001017\t2101000834\n2090001099\t2101000079\n2090001309\t2101000083\n2090001393\t2101000214\n2090001410\t2101000119\n2090001424\t2101000324\n2090001550\t2101000889\n2090001556\t2101000973\n2090001591\t2101000075\n2090001656\t2101000860\n2090001700\t2101000902\n2090001740\t2101000888\n2090001780\t2101000994\n2090001786\t2101000139\n2090001860\t2101000577\n2090001871\t2101000616\n2090001872\t2101000173\n2090001886\t2101000310\n2090002308\t2101001008\n2090002339\t2101000128\n2090002341\t2101000376\n2090002447\t2101000374\n2090002462\t2101000777\n2090002487\t2101000459\n2090002530\t2101000785\n2090002551\t2101000231\n2090002572\t2101000136\n2090002692\t2101000273\n2090002730\t2101000342\n2090002742\t2101000312\n2090002768\t2101000833\n2090002798\t2101000118\n2090002810\t2101000895\n2090002824\t2101000248\n2090002847\t2101000225\n2090002911\t2101000773\n2090002964\t2101000252\n2090002969\t2101000890\n2090002976\t2101000816\n2090003009\t2101000474\n2090003024\t2101000993\n2090003100\t2101000821\n2090003101\t2101000830\n2090003110\t2101000946\n2090003126\t2101000288\n2090003170\t2101000670\n2090003245\t2101000865\n2090003248\t2101000285\n2090003314\t2101000333\n2090003315\t2101000341\n2090003318\t2101000353\n2090003326\t2101000308\n2090003358\t2101000360\n2090003379\t2101000817\n2090003384\t2101000820\n2090003390\t2101000715\n2090003394\t2101000792\n2090003415\t2101000343\n2090003456\t2101000350\n2090003540\t2101000397\n2090003551\t2101000418\n2090003553\t2101000385\n2090003555\t2101000403\n2090003556\t2101000608\n2090003574\t2101000421\n2090003658\t2101000440\n2090003672\t2101000716\n2090003674\t2101000451\n2090003739\t2101000835\n2090003805\t2101000829\n2090003818\t2101000480\n2090003819\t2101000482\n2090003820\t2101000794\n2090003822\t2101000468\n2090003922\t2101000823\n2090003941\t2101000793\n2090004065\t2101000579\n2090004138\t2101000705\n2090004188\t2101000656\n2090004224\t2101000824\n2090004229\t2101000825\n2090004299\t2101000795\n2090004300\t2101000796\n2090004389\t2101000782\n2090004412\t2101000808\n2090004414\t2101000891", "firm_fei_number": "2024800", "recalling_firm": "Hologic, Inc.", "address_1": "10210 Genetic Center Dr", "city": "San Diego", "state": "CA", "postal_code": "92121-4362", "additional_info_contact": "Ryan Simon\n858-275-0032 Ext. 128", "reason_for_recall": "Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.", "root_cause_description": "Under Investigation by firm", "action": "On 12/15/2023, the firm send an \"URGENT: MEDICAL DEVICE RECALL\" Letter via FedEx 2-day delivery to customer informing them that the firm has became aware of potential erroneous influenza B virus (FLU B) positive results when testing with the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay on the Panther Fusion System.\n\nCustomers are instructed to:\n 1. They may continue to test with the Panther Fusion SARS-CoV-2/Flu A/B/RTSV assay on the Panther Fusion System.\n2. Hologic has partnered with Novasyte, an IQVIA MedTech company, to assist in the recall. Acknowledge receipt of the notification by completing the Customer Acknowledgement Form located at https;//iqvia-response.my.site.com/mt/fca?cid=HPAN23\n3. To ensure visibility of the issue, Hologic recommends posting the notification on or near the Panther Fusion Systems that are running the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.\n4. If customers suspect a false Flu B positive result in combination with SARS-CoV-2 positive result (dual positive), contact Hologic Technical Support for evaluation and/or troubleshooting.\n\nFor questions or assistance, contact Hologic Technical Support. Country-specific telephone and email contact information for Technical Support can be found at www.hologic.com/support.", "product_quantity": "771 systems (of which 313 are potentially impacted)", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AK, AR, CA, CO, CT, FL, IL, IN, MA, ME, MI, MN, MO, MT, NC, ND, NH, NJ, NM, NV, NY, OH, PA, Puerto Rico, TX, UT, VA, VI, WA, WI, and WV. The countries of Austria, Australia, Belgium, Dominican Republic, Switzerland, Germany, Denmark, Spain, France, Great Britain, Hong Kong, Ireland, Italy, Korea, Kuwait, The Netherlands, Norway, New Zealand, Portugal, Qatar, and Sweden.", "openfda": { "k_number": [ "K161495", "K243922", "K102314", "K092705", "K093383", "K151690", "K113319", "K151917", "K170558", "K140447", "K220480", "K222779", "K160517", "K123955" ], "registration_number": [ "", "8043379", "3042971506", "3002773840", "2024800", "3022977716", "3006198300", "3007867838", "3003540236", "3043088937", "1650733", "3009297077", "3026886124", "2024674", "3020925311", "3008494306", "3011461582", "3005748784", "3005118020", "3016838963", "3009972873", "3004530258", "3003673482", "3016548670", "3003795116", "3019946577", "3008318433", "3024647994", "3009984016", "3025430789", "2023365", "3011781554", "1119779", "3016619649", "3007923088", "3008517993", "3014325803", "1221359", "3009155756", "3003030793", "3012494290", "3004013603", "3012598266", "3017644086", "3007799234", "3016837106", "3003537036", "9610126", "3006028115", "3009609218", "3029059580", "3009875001", "1524213", "2243471", "9610240", "1528450", "3003083993", "3007420875", "3012918440", "3019837962", "3026940910", "3043138885", "3027645317", "3005248192", "3014661462", "3004061467", "3012449645", "3003402518", "3003366417", "1550222", "3005748564", "3004141078", "3002777243", "3009613136", "3023372670", "3008754394", "3003018722", "2022994", "3016635427", "3012259842" ], "fei_number": [ "", "3042971506", "3002773840", "2024800", "3022977716", "3006198300", "3003540236", "3043088937", "3009297077", "3026886124", "2024674", "3020925311", "3008494306", "3011461582", "3005748784", "3016838963", "3009972873", "3004530258", "3003673482", "3016548670", "3003795116", "3019946577", "3008318433", "3024647994", "3009984016", "3025430789", "2023365", "1000161215", "3011781554", "1119779", "3016619649", "3007923088", "3008517993", "3002808212", "3014325803", "1221359", "3002524000", "3009155756", "3003030793", "3002806559", "3012494290", "3004013603", "3012598266", "3017644086", "3007799234", "3016837106", "3003537036", "3009391812", "3006028115", "3009609218", "3029059580", "3009875001", "1524213", "2243471", "3003083993", "3007420875", "3012918440", "3019837962", "3026940910", "3043138885", "3027645317", "3005248192", "3014661462", "3004061467", "3012449645", "3003402518", "3003413192", "3003366417", "1550222", "3005748564", "3004141078", "3002777243", "3009613136", "3023372670", "3008754394", "3003018722", "2022994", "3016635427", "1000122536", "3012259842" ], "device_name": "Real Time Nucleic Acid Amplification System", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2570", "device_class": "2" } } ] }