{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "94142", "product_res_number": "Z-0123-2011", "event_date_initiated": "2010-08-27", "event_date_posted": "2010-10-22", "recall_status": "Terminated", "event_date_terminated": "2011-07-15", "res_event_number": "56627", "product_code": "JQP", "product_description": "GE Centricity Laboratory Instrument Interface software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval.", "code_info": "Software Version 3.3 and newer.", "firm_fei_number": "3004526608", "recalling_firm": "Ge Healthcare It", "address_1": "540 W Northwest Hwy", "city": "Barrington", "state": "IL", "postal_code": "60010-3051", "reason_for_recall": "Instrument may incorrectly report the result of an antimicrobial sensitivity test.", "root_cause_description": "Software design", "action": "The firm, GE Healthcare, sent \"Urgent Medical Device Correction\" letters dated August 27, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the patient safety issue associated with the use of GE Centricity Laboratory instrument interface to Biomerieux's Vitek analyzer where results may be incorrectly reported. The letters provided the users with specific safety instructions to follow until the software is updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions should be directed to their GE Service Representative or the GE Help desk at 888-778-3375.", "product_quantity": "22 units", "distribution_pattern": "Worldwide Distribution -- USA, including states of Georgia, Michigan, Minnesota, New York, Ohio, Oregon, Tennessee, and Texas and countries of Australia, Canada, England, India, New Zealand, Qatar, and Scotland.", "openfda": { "k_number": [ "K833353", "K803312", "K871853", "K832746", "K861412", "K810631", "K823785", "K831574", "K822381", "K113007", "K821058", "K831830", "K801167", "K831838", "K861844", "K861778", "K801664", "K800242", "K822778", "K822932", "K934111", "K822860", "K844907", "K885292", "K834490", "K923316", "K802594", "K842401", "K812604", "K781081", "K760739", "K864557", "K834300", "K790336", "K781173", "K964460", "K800724", "K892060", "K881194", "K820427", "K871339", "K821807", "K810063", "K830296", "K792158", "K851321", "K802471", "K770671", "K850659", "K801210", "K823679", "K781217", "K761063", "K790543", "K823110", "K801438", "K780881", "K853026", "K832760", "K861779", "K782052", "K983468", "K953652", "K770877", "K800282", "K843365", "K802251", "K800241", "K801131", "K792129", "K821531", "K840502", "K893838", "K801091", "K810968", "K822146", "K854265", "K820721" ], "registration_number": [ "3003795116", "3043012074", "3015426626", "3002809144", "9610865", "2432235", "3031570369", "3004032053", "3005798890", "3015058854", "9610126", "3003618481", "3015633428", "3011194542", "3006543086", "3004145393", "3011806823", "3015347724", "3017086896", "3040278125", "3013896610", "3011121740", "3009404844", "3003825930", "3002637618", "2029302", "3006371704", "1810909", "3006755541", "2431530", "3004959793", "3043012240", "3027486032", "9710492", "3038419886", "3042228064", "1000113657", "3009129531", "8020888", "3005509212", "9616936", "3003600763", "3013922172", "1219145", "3016764932", "3010097171", "3010258456", "3010141591", "9615754", "3006677029", "3011393376", "3002807715", "2245451", "3009731198", "3013298431", "3042989733", "1225673", "3016438761", "3024512705", "3013646951", "2936921", "9610816", "3030413550", "1061932", "3021394862", "3037000637", "3020978007", "3009711478", "3010900203", "9615507", "1119779", "3005333358", "3023268435", "3003559191", "8030392", "3004838836", "3002710220", "1950204", "3012118659", "3003995437", "3008514395", "3011187792", "3027496319", "3003902721", "3015967359", "2243471", "3002889627", "3005862821", "8043909", "3007134734", "3009288740", "2954323", "3025376092", "3012104009", "3015738702", "3035708936", "8020030", "3010825766", "1058332", "1220649", "3008789114", "9614673", "3002821232", "3012436569", "3014840402", "2531491", "3030714692", "3009542936", "3015969360", "3004973408", "3000148879", "2517506", "9616530", "3003453957", "8043723", "3000126629", "3008802064" ], "fei_number": [ "3003795116", "3043012074", "3015426626", "3002809144", "2432235", "3031570369", "3004032053", "3005798890", "3015058854", "3003516723", "3003618481", "3015633428", "3011194542", "3006543086", "3004145393", "3011806823", "3015347724", "3017086896", "3040278125", "3013896610", "3003500908", "3009404844", "3001451449", "3003825930", "3002637618", "3006371704", "3003116995", "1810909", "3002808498", "3006755541", "3003559576", "3006461677", "2431530", "3004959793", "3002807167", "3007019572", "3001573851", "3043012240", "3027486032", "3042228064", "3038419886", "1000113657", "1000307651", "3009129531", "3005509212", "3003600763", "3013922172", "1219145", "3016764932", "3002829675", "3010097171", "3010258456", "3010141591", "3006677029", "3011393376", "3002807715", "2245451", "3009731198", "3013298431", "3042989733", "3016438761", "3024512705", "3013646951", "2936921", "3030413550", "3021394862", "3037000637", "3009711478", "3020978007", "3010900203", "1119779", "3005333358", "3023268435", "3003559191", "3004838836", "3002710220", "1950204", "3012118659", "3003995437", "3008514395", "3011187792", "3027496319", "3003902721", "3002806559", "3002671736", "3015967359", "3002806350", "3002803444", "2243471", "3002889627", "3005862821", "3007134734", "3009288740", "3025376092", "3000203293", "3012104009", "3015738702", "3035708936", "3010825766", "3008237827", "3010700165", "1220649", "3008789114", "3002821232", "3012436569", "3014840402", "3030714692", "3009542936", "3015969360", "3004973408", "3000148879", "2517506", "3003453957", "1000306472", "3000126629", "3008802064" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }