{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "186269", "product_res_number": "Z-1369-2021", "event_date_initiated": "2021-02-26", "event_date_created": "2021-04-07", "recall_status": "Open, Classified", "res_event_number": "87557", "product_code": "NSU", "product_description": "Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.", "code_info": "Part No. (PN) FAB-15004 (Box Lot Number)/Catalog No PRD-0400 (Box/Tray Lot Number)  285762 / 647288, 285765 / 647288, 286025 / 648958, 286026 / 648958, 286028 / 648959, 286852 / 650655, 287410 / 650656, 289297 / 648959, 290057 / 647288, 290068/654833, 290409 / 654833, 291425 / 657545", "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": "Hologic Technical Support\n888-484-4747", "reason_for_recall": "There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.", "root_cause_description": "Nonconforming Material/Component", "action": "On February 26, 2021, Hologic, issued \"Urgent: Medical Device Recall Notification\" to affected consignees via FedEx. In addition, to informing consignees about the recall, they asked customers to take the following actions:\n\nLaboratory Action:\n\nA. Please immediately discontinue use of the Panther Fusion Tube Tray lots listed in Table 1.\nB. Please immediately check your inventory and segregate the Panther Fusion Tube Tray lots listed in Table 1. \nC. The number of tube tray boxes shipped to your site is identified on the accompanying document. (GBS customers will receive a blank form and will need to fill in lot number and quantity.)\n\n- Please fill out the documents completely, including the number of boxes of the specified lots remaining in inventory (whether unopened or partial boxes). \n- After completing the document, destroy the segregated inventory. \n- Sign the document to signify compliance and return it as instructed on the document. \n- Please do this even if you do not have any of the affected trays remaining in your inventory. \nD. Hologic will ship replacement product to your site based on the number of boxes of the specified lots you list as remaining in your inventory on the document you return. \nE. Please ensure that appropriate laboratory personnel are notified of the information herein. \nF. If you have any questions or concerns about this notification or about the replacement product, please contact Hologic Technical Support at 1888-484-474- or molecularsupport@hologic.com", "product_quantity": "1355 kits", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, IN, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, TX, UT, VA, VT, WA, WI, WV and the countries of Austria (AT), Belgium (BE), France (FR), Germany (DE), Great Britain (GB), Italy (IT) Netherlands (NL), Spain (ES), Switzerland (CH),, Canada (CA), Hong Kong (HK), Australia (AU), New Zealand (NZ).", "openfda": { "k_number": [ "K082562", "K110786", "K073506", "K163652", "K141220", "K133302", "K070597", "K080995", "K133849", "K143178", "K093128", "DEN040012", "K121399" ], "registration_number": [ "1650733", "1628664", "3017019647", "3007799234", "3014515702", "3017358793", "3003673482", "3005406097", "3032023483", "3042641161", "1119779", "3016531205", "3008494306", "3004105270", "3007143373", "3008632402", "2183715", "3007208259", "3010461097", "3004141078", "3007719797", "3016733849", "9615056", "3012259842", "3009189893", "3002777243", "3007420875", "3014325803", "3013019728", "3002773840", "3007361513", "3012348571", "3038610665", "3017907743", "3003423869", "8043379", "3007886270", "3016611336", "8020030", "2915274", "3005370583", "3003314809", "2243471", "9610126", "3006028115", "3004530258", "3006198300", "2024800", "3003366417", "3013540184", "2026994", "3010770794", "3003795116", "3010286073", "3016838963", "3014214006", "3005269352", "2032682", "3035381641", "3021389305", "3016068451", "3007118747", "3005967741" ], "fei_number": [ "3002806559", "3003952975", "1628664", "3017019647", "3008272466", "3007799234", "3014515702", "3017358793", "1000186023", "3003673482", "3005406097", "3032023483", "3006461677", "1119779", "3016531205", "3008494306", "3042641161", "3004105270", "3007143373", "3008632402", "2183715", "3007208259", "3010461097", "3004141078", "3007719797", "3016733849", "3012259842", "3009189893", "3002777243", "3007420875", "3014325803", "3013019728", "3002773840", "3007361513", "3012348571", "3038610665", "3017907743", "3003423869", "3016611336", "2915274", "3005370583", "3003314809", "2243471", "3006028115", "3003413192", "3004530258", "3006198300", "2024800", "3003366417", "3013540184", "2026994", "3002524000", "3010770794", "3003795116", "3010286073", "3016838963", "3014214006", "3005269352", "3035381641", "3021389305", "3016068451", "3007118747", "3005967741" ], "device_name": "Instrumentation For Clinical Multiplex Test Systems", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2570", "device_class": "2" } } ] }