{ "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": "2026-09-28", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "205002", "product_res_number": "Z-1140-2024", "event_date_initiated": "2024-01-26", "event_date_posted": "2024-02-15", "recall_status": "Open, Classified", "res_event_number": "93639", "product_code": "PCH", "k_numbers": [ "K140407", "K143005", "K160459", "K230404" ], "product_description": "FilmArray Gastrointestinal (GI) Panel\nRFIT-ASY-0116 (30 test kit)\nRFIT-ASY-0104 (6 test kit)\n\nGastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.", "code_info": "Part No.: RFIT-ASY-0116 (30 test kit)\nUDI-DI code: 00815381020109\n\n\nPart No. RFIT-ASY-0104 (6 test kit)\nUDI-DI code: 0081538102011", "firm_fei_number": "3002773840", "recalling_firm": "BioFire Diagnostics, LLC", "address_1": "515 S Colorow Dr", "city": "Salt Lake City", "state": "UT", "postal_code": "84108-1248", "additional_info_contact": "Customer Support Department\n800-736-6354 Ext. 5", "reason_for_recall": "Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.", "root_cause_description": "Under Investigation by firm", "action": "On 01/262024, the firm sent an \"URGENT: MEDICAL DEVICE RECALL\" Letter via overnight FedEx to customers to inform them of the increased risk of false positive Norovirus results when the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel.\n\nCustomers are requested to take the following actions:\nIn this context, we request you to take the following actions. Please:\n- Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product.\n- If a positive Norovirus result is inconsistent with clinical presentation, the positive Norovirus result should be confirmed using another method.\n- Complete the Acknowledgement Form in Attachment A (on the following page) and return it to bioMerieux to confirm receipt of this notice. It is important that you return the acknowledgement form to bioMerieux even if you determine that this urgent product correction notice does not impact your facility.\n\nFor questions/assistance contact BIOFIRE Technical Support Team at biofiresupport@biomerieux.com or via telephone at 1-800-735-6544 and select option 5.", "product_quantity": "64,594 kits (equals 2,303,760 tests)", "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, US Virgin Island, VT, WA, WI, WV, and WY. The countries of Andorra, United Arab Emirates, Albania, Armenia, Argentina, Austria, Australia, Bosnia, Belgium, Bulgaria, Bahrain, Bermuda, Bolivia, Brazil, Botswana, Canada, Congo, Switzerland, Cote D'Ivoire, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, Fiji, France, United Kingdom, Georgia, French Guiana, Gibraltar, Guadeloupe, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Iceland, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Korea, Kuwait, Lebanon, Lithuania, Latvia, Morocco, Macedonia, Mali, Myanmar, Mongolia, Macau, Mauritania, Mexico, Malaysia, Namibia, New Caledonia, Nigeria, Nicaragua, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, French Polynesia, Papua New Guinea, Philippines, Poland, St. Pierre/Miquelon, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, El Salvador, Thailand, Tunisia, Turkey, Taiwan, Uganda, Uruguay, Vatican City, Venezuela, Vietnam, South Africa, and Zimbabwe.", "openfda": { "k_number": [ "K170308", "K152955", "K253722", "K190585", "K220607", "K143005", "K140083", "K220193", "K242367", "DEN130003", "K251868", "K232672", "K140377", "K251993", "K242877", "K191161", "K142033", "K121894", "K254032", "K230404", "K252329", "K220062", "K140647", "K183023", "K251721", "K123274", "K243885", "K250324", "K160459", "K180041", "K182703", "K191160", "K142501", "K181427", "K143648", "K183030", "K243813", "K140407" ], "registration_number": [ "3007799234", "1119779", "3010749841", "3002777243", "3004530258", "3007420875", "3014553740", "2024800", "1650733", "3009613136", "3006028115", "3016838963", "3005360469", "3004013603", "3002773840", "3011781554" ], "fei_number": [ "3005670738", "3007799234", "1119779", "3010749841", "3002777243", "3004530258", "3007420875", "3002524000", "2024800", "3009613136", "3006028115", "3016838963", "3014553740", "3004013603", "3002773840", "3011781554" ], "device_name": "Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System", "medical_specialty_description": "Microbiology", "regulation_number": "866.3990", "device_class": "2" } } ] }