{ "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": "211800", "product_res_number": "Z-0836-2025", "event_date_initiated": "2024-12-10", "event_date_posted": "2025-01-10", "recall_status": "Open, Classified", "res_event_number": "96022", "product_code": "OOI", "product_description": "Idylla INSTRUMENT, IVD, REF P0010.\nIntended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.", "code_info": "UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445.", "firm_fei_number": "3009972873", "recalling_firm": "Biocartis Nv", "address_1": "B 3 11 generaal de wittelaan", "city": "Mechelen", "country": "Belgium", "reason_for_recall": "False-positive MSI-H results generated by the Idylla MSI Test.", "root_cause_description": "Environmental control", "action": "Biocartis issued an URGENT - Medical Device Correction notice to its consignees on 12/10/2024 via email. The notice provided the description of the problem, its impact, and requested the following actions be taken: \n1. Until your Instrument is serviced, please move forward with the option that applies to your situation:\no In case you have another Idylla Instrument available that is not affected, use that\nInstrument to run the Idylla MSI Test and discontinue running the Idylla MSI Test on the\nlisted Instrument(s).\no No new Idylla MSI testing should be performed using the affected Idylla Instruments.\no For results already obtained using an affected Idylla Instrument, the following apply:\no MSS results are VALID and may be reported.\no MSI-H (Microsatellite Instability High) results with six or seven positive identified\nbiomarkers (as depicted in the result report) are VALID and may be reported.\no MSI-H results other than those with six or seven positive identified biomarkers are\nINVALID and should NOT be reported or used to manage patient health. Patient samples with these results should be re-tested on an Idylla Instrument that is NOT affected.\n2. If you are not the Idylla user, please forward this notice to the Idylla end user or Idylla\nsupervisor and provide Biocartis with the correct contact details for our record keeping.\n3. Completion of the Acknowledgement of Receipt (Appendix 2) is required for compliance. Please complete and sign the attached Acknowledgement of Receipt form by December 17, 2024, and send it to vigilance@biocartis.com.", "product_quantity": "8 units", "distribution_pattern": "US: AL, NJ, TX, OH, CA", "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" } } ] }