{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "66375", "product_res_number": "Z-0551-2008", "event_date_initiated": "2007-10-25", "event_date_posted": "2008-01-25", "recall_status": "Terminated", "event_date_terminated": "2008-04-01", "res_event_number": "45873", "product_code": "JQP", "product_description": "Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL", "code_info": "All Serial Numbers.", "firm_fei_number": "1628664", "recalling_firm": "Abbott Laboratories, Inc", "address_1": "1921 Hurd Drive", "address_2": "PO Box 152020", "city": "Irving", "state": "TX", "postal_code": "75038", "additional_info_contact": "972-518-6154", "reason_for_recall": "Sample/Patient Mis-identification: Two issues identified related to the ACCELERATOR Decision Manager (ADM), to include: 1) Sample Identification (SID) and/or Patient Identification (PID) numbers that contain more than 12 characters are truncated to the final 12 characters by the ADM; 2) for SIDs using alpha characters that are case sensitive, SIDs with lower case characters are transmitted by the", "root_cause_description": "Software design", "action": "Firm notified consignees via Product Correction, Immediate Action Required letter(s) on 10/25/07. Consignees were notified of software issues and informed they would be contacted by an Abbott representative to schedule installation of software upgrade.", "product_quantity": "19 units.", "distribution_pattern": "Nationwide:Distributed to hospitals/laboratories in IL, PA, TN, TX, UT, VA and WV.", "openfda": { "k_number": [ "K861412", "K802251", "K801091", "K800241", "K821531", "K810968", "K802594", "K800282", "K810063", "K893838", "K983468", "K854265", "K790543", "K801131", "K760739", "K964460", "K820721", "K831838", "K871853", "K822778", "K822146", "K810631", "K802471", "K885292", "K781173", "K822860", "K853026", "K861844", "K790336", "K831830", "K840502", "K844907", "K822381", "K781081", "K770877", "K871339", "K832746", "K934111", "K842401", "K822932", "K953652", "K792158", "K801167", "K823785", "K834490", "K770671", "K761063", "K800724", "K832760", "K781217", "K801210", "K843365", "K821807", "K113007", "K780881", "K823110", "K861779", "K861778", "K823679", "K803312", "K812604", "K792129", "K801664", "K923316", "K851321", "K800242", "K831574", "K834300", "K864557", "K850659", "K892060", "K782052", "K830296", "K821058", "K833353", "K820427", "K801438", "K881194" ], "registration_number": [ "2243471", "3007134734", "3002807715", "8030392", "2954323", "3003825930", "3015738702", "3012118659", "8043723", "3010097171", "3040278125", "9610126", "3002889627", "3017086896", "9615507", "1220649", "3031570369", "1950204", "3011121740", "1119779", "3002637618", "3008789114", "3003453957", "3023268435", "3009129531", "3004838836", "3003559191", "3011393376", "2517506", "3042228064", "9614673", "3003795116", "1058332", "3004032053", "3005862821", "3024512705", "3003618481", "3009288740", "9610865", "3010258456", "9616530", "1061932", "3025376092", "9710492", "8020888", "3011806823", "3011187792", "3006543086", "3015347724", "3010900203", "3035708936", "3015426626", "3005798890", "3021394862", "1225673", "2245451", "3013298431", "3014840402", "3043012074", "3009731198", "3016438761", "1000113657", "3012104009", "3015967359", "2936921", "3015633428", "3043012240", "9610816", "3005509212", "3013896610", "3009542936", "3000126629", "2431530", "3037000637", "3027486032", "3042989733", "3005333358", "3012436569", "1219145", "3004973408", "3008802064", "8020030", "3000148879", "3013922172", "2432235", "3015058854", "3011194542", "3002809144", "3020978007", "9616936", "1810909", "2531491", "3009404844", "3030413550", "3006677029", "3003600763", "3030714692", "3002710220", "3008514395", "9615754", "3010141591", "3002821232", "3006371704", "3006755541", "3010825766", "3003995437", "3003902721", "3013646951", "3015969360", "3038419886", "8043909", "3027496319", "3004145393", "3009711478", "3004959793", "3016764932", "2029302" ], "fei_number": [ "2243471", "3007134734", "3002807715", "3002806350", "3003825930", "3015738702", "3010700165", "3012118659", "3010097171", "3040278125", "3002889627", "3017086896", "3031570369", "1220649", "1950204", "1000306472", "1119779", "3002637618", "3008789114", "1000307651", "3003453957", "3023268435", "3009129531", "3004838836", "3003559191", "3011393376", "2517506", "3042228064", "3002671736", "3003795116", "3004032053", "3005862821", "3024512705", "3003618481", "3009288740", "3002829675", "3001573851", "3010258456", "3025376092", "3007019572", "3002807167", "3003559576", "3011806823", "3011187792", "3006543086", "3015347724", "3010900203", "3035708936", "3015426626", "3005798890", "3021394862", "2245451", "3013298431", "3014840402", "3043012074", "3009731198", "3016438761", "1000113657", "3012104009", "3006461677", "3015967359", "2936921", "3015633428", "3002808498", "3043012240", "3001451449", "3005509212", "3013896610", "3009542936", "3000126629", "2431530", "3037000637", "3027486032", "3042989733", "3005333358", "3012436569", "1219145", "3004973408", "3003500908", "3003116995", "3002803444", "3008802064", "3000148879", "3013922172", "2432235", "3015058854", "3011194542", "3002809144", "3020978007", "3000203293", "1810909", "3003516723", "3009404844", "3030413550", "3002806559", "3006677029", "3003600763", "3030714692", "3002710220", "3008237827", "3008514395", "3010141591", "3002821232", "3006371704", "3006755541", "3010825766", "3003995437", "3003902721", "3013646951", "3015969360", "3038419886", "3027496319", "3004145393", "3009711478", "3004959793", "3016764932" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }