{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197412", "product_res_number": "Z-0952-2023", "event_date_initiated": "2022-12-12", "event_date_posted": "2023-01-12", "recall_status": "Open, Classified", "res_event_number": "91299", "product_code": "JQP", "product_description": "cobas infinity central lab, Material Number 07154003001", "code_info": "cobas infinity central lab / cobas infinity core license using software versions (2.5.x , 3.01.x, 3.02.x, and 3.03.x) that have been configured with all of the following pre-conditions will be impacted:\n1. Having Order ID configuration to include the date (Not Common in U.S. Configurations)\n2. Having a host configured by Order rather than Tube (Not Common in U.S..Configurations)\n3. Having message configured to receive registration date of the order using ExtRegisterDate and\nExtRegisterHour.\n4. Having HCA configuration enabled for \" Reject orders if not possible to assign External ID\"\nand the radio button option set to \"To at least one test\"\n\nUDI-DI 04015630936007", "firm_fei_number": "1823260", "recalling_firm": "Roche Diagnostics Operations, Inc.", "address_1": "9115 Hague Rd", "city": "Indianapolis", "state": "IN", "postal_code": "46256-1025", "additional_info_contact": "Roche Support Network Customer Support Center\n800-526-2272", "reason_for_recall": "A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.", "root_cause_description": "Software design", "action": "On December 12, 2022, the firm notified affected customers through Urgent Medical Device Correction letters.\n\nCustomers were informed of the product issue. A Roche Diagnostics representative will contact you in the near future to assess your cobas infinity configuration and to determine if it meets all pre-conditions. If so, your Roche representative will work with you to implement a workaround immediately in addition to working with you to apply a more permanent solution via a software patch once available.\n\nCustomers should consult with a physician or pathologist at your facility to determine clinical implications specific to your patients.\n\nPlease contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272 if you have questions about this recall.", "product_quantity": "224 US; 2,797 worldwide", "distribution_pattern": "Domestic distribution nationwide. Foreign distribution pending.", "openfda": { "k_number": [ "K843365", "K800241", "K781173", "K934111", "K871853", "K781081", "K871339", "K800282", "K831838", "K822932", "K803312", "K821531", "K850659", "K923316", "K782052", "K800724", "K780881", "K964460", "K770671", "K802471", "K861778", "K822381", "K885292", "K802594", "K790336", "K842401", "K851321", "K861412", "K823110", "K864557", "K812604", "K854265", "K801167", "K822146", "K832746", "K832760", "K802251", "K853026", "K820427", "K801438", "K810063", "K800242", "K820721", "K834300", "K801131", "K792158", "K823679", "K113007", "K801091", "K770877", "K822860", "K844907", "K892060", "K821807", "K781217", "K893838", "K790543", "K831574", "K821058", "K861779", "K801210", "K810631", "K810968", "K760739", "K833353", "K822778", "K953652", "K861844", "K823785", "K761063", "K792129", "K881194", "K831830", "K983468", "K834490", "K830296", "K801664", "K840502" ], "registration_number": [ "2954323", "3015058854", "3009404844", "1061932", "2531491", "3042989733", "3011121740", "3004032053", "3023268435", "3027486032", "8020888", "3003618481", "3011806823", "3037000637", "1119779", "3002710220", "3003795116", "3003559191", "3013298431", "3020978007", "2936921", "3008802064", "3042228064", "3005509212", "3000148879", "3010900203", "3030413550", "3043012240", "3013896610", "1220649", "3011393376", "8030392", "3002889627", "3013922172", "3010097171", "9616936", "9615507", "8043909", "3012118659", "3015347724", "2431530", "3007134734", "3006371704", "3015969360", "1219145", "3009288740", "2029302", "3003600763", "3003825930", "1225673", "1058332", "3015967359", "3002821232", "3004145393", "3003995437", "3027496319", "3006543086", "8020030", "3004959793", "3004973408", "3002637618", "1810909", "9615754", "3002809144", "3008789114", "3005798890", "3004838836", "3008514395", "8043723", "3015426626", "9710492", "3003453957", "1000113657", "3015633428", "3043012074", "9610816", "3016438761", "3006755541", "3006677029", "3017086896", "3035708936", "3012436569", "3012104009", "3002807715", "3009542936", "3021394862", "3011194542", "3010258456", "9610865", "3003902721", "3025376092", "3005333358", "3038419886", "3030714692", "2245451", "3009731198", "3024512705", "2517506", "1950204", "3011187792", "3010141591", "3015738702", "3014840402", "3009129531", "9610126", "3031570369", "3000126629", "3016764932", "3005862821", "3009711478", "3013646951", "2243471", "3010825766", "9616530", "9614673", "2432235", "3040278125" ], "fei_number": [ "3015058854", "3009404844", "3042989733", "3002671736", "1000306472", "3004032053", "3023268435", "3027486032", "3003618481", "3011806823", "3037000637", "1119779", "3002710220", "3003795116", "3003559191", "3013298431", "3020978007", "2936921", "3008802064", "3042228064", "3005509212", "3000148879", "3002807167", "3007019572", "3010900203", "3030413550", "3043012240", "3003500908", "3013896610", "1220649", "3011393376", "3002889627", "3010700165", "3013922172", "3010097171", "3012118659", "3015347724", "2431530", "3007134734", "3001451449", "3006371704", "1000307651", "3015969360", "1219145", "3009288740", "3003600763", "3003825930", "3015967359", "3008237827", "3002821232", "3000203293", "3004145393", "3003995437", "3003516723", "3027496319", "3006543086", "3004959793", "3004973408", "3001573851", "3002637618", "3003559576", "1810909", "3003116995", "3002808498", "3002809144", "3008789114", "3005798890", "3004838836", "3008514395", "3015426626", "3003453957", "1000113657", "3015633428", "3002806559", "3043012074", "3016438761", "3006755541", "3006677029", "3017086896", "3035708936", "3012436569", "3012104009", "3002807715", "3009542936", "3021394862", "3011194542", "3010258456", "3003902721", "3025376092", "3005333358", "3038419886", "3030714692", "3002806350", "2245451", "3009731198", "3024512705", "3002803444", "2517506", "1950204", "3011187792", "3010141591", "3015738702", "3014840402", "3009129531", "3031570369", "3000126629", "3016764932", "3005862821", "3009711478", "3013646951", "2243471", "3010825766", "3006461677", "2432235", "3040278125", "3002829675" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }