{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "65475", "product_res_number": "Z-0257-2008", "event_date_initiated": "2007-10-10", "event_date_posted": "2007-11-24", "recall_status": "Terminated", "event_date_terminated": "2008-03-10", "res_event_number": "45429", "product_code": "JQP", "product_description": "Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064", "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 problems; Five issues identified related to software utilized by the ACCELERATOR APS System Input/Output Module, to include: Under three specific conditions, the post-aspiration radio-frequency identification (RF ID) read of the tube carrier is not performed and the APS work cell may not appropriately generate Sample Presentation/Sample Queue errors with APS software version 1.1.1 or earlie", "root_cause_description": "Software design", "action": "Firm notified consignee via letter on 11/10/07. Consignee notified of software issues and informed they would be contacted by an Abbott representative to schedule installation of software upgrade.", "product_quantity": "1 unit.", "distribution_pattern": "Nationwide: including state of UT.", "openfda": { "k_number": [ "K833353", "K844907", "K802471", "K780881", "K800724", "K801167", "K761063", "K861779", "K893838", "K831830", "K810968", "K790543", "K830296", "K792129", "K983468", "K821531", "K113007", "K812604", "K801438", "K760739", "K800241", "K810631", "K770671", "K871339", "K823785", "K851321", "K782052", "K802251", "K822146", "K892060", "K953652", "K820427", "K801131", "K821058", "K801091", "K864557", "K934111", "K850659", "K790336", "K801210", "K822932", "K832746", "K822381", "K821807", "K861778", "K810063", "K881194", "K792158", "K801664", "K854265", "K834490", "K861844", "K823110", "K843365", "K871853", "K834300", "K802594", "K885292", "K822860", "K831574", "K831838", "K853026", "K770877", "K803312", "K822778", "K964460", "K781217", "K923316", "K820721", "K781173", "K861412", "K832760", "K800282", "K823679", "K840502", "K842401", "K781081", "K800242" ], "registration_number": [ "3020978007", "3008789114", "3015967359", "3031570369", "9616936", "3012104009", "9710492", "3015969360", "3003618481", "3010141591", "2029302", "3002807715", "2245451", "3010258456", "3008802064", "1220649", "3004145393", "3003453957", "1061932", "3003995437", "3002889627", "1225673", "3006543086", "8043723", "3042228064", "3011194542", "9615754", "3043012074", "3011806823", "3016764932", "1810909", "3006677029", "3009542936", "2243471", "9610126", "3027486032", "3021394862", "9615507", "3012436569", "8020888", "9616530", "3010097171", "2936921", "2431530", "3043012240", "3000126629", "3009404844", "3009731198", "3013896610", "3005798890", "3042989733", "3004959793", "9610865", "3003825930", "8030392", "3009711478", "3015426626", "3023268435", "8020030", "3038419886", "3007134734", "3015738702", "3002809144", "2531491", "3017086896", "3003559191", "3012118659", "3030413550", "9614673", "1058332", "3011393376", "3000148879", "3002710220", "2517506", "3005509212", "3037000637", "3011121740", "3003795116", "3003600763", "3002637618", "3010825766", "3006371704", "2432235", "1119779", "3015633428", "3006755541", "3004838836", "1950204", "3005862821", "9610816", "3013922172", "3013646951", "3035708936", "3024512705", "3030714692", "3009129531", "3011187792", "3025376092", "3010900203", "3008514395", "3040278125", "1000113657", "3016438761", "3002821232", "3015058854", "3004032053", "3009288740", "3013298431", "3003902721", "2954323", "8043909", "3027496319", "3015347724", "3005333358", "3004973408", "3014840402", "1219145" ], "fei_number": [ "3020978007", "3008789114", "3003516723", "3015967359", "3031570369", "3010700165", "3012104009", "3015969360", "3003618481", "3010141591", "3002807715", "2245451", "3001451449", "3010258456", "3008237827", "3008802064", "1220649", "3002803444", "3004145393", "3003453957", "3003116995", "3003559576", "3003995437", "3002889627", "3006461677", "3006543086", "3042228064", "1000306472", "3011194542", "3043012074", "3000203293", "3011806823", "3016764932", "1810909", "3006677029", "3009542936", "2243471", "3002829675", "3027486032", "3021394862", "3002806559", "3012436569", "1000307651", "3010097171", "2936921", "2431530", "3043012240", "3000126629", "3009404844", "3009731198", "3013896610", "3005798890", "3042989733", "3004959793", "3003825930", "3009711478", "3015426626", "3023268435", "3038419886", "3007134734", "3003500908", "3015738702", "3002809144", "3017086896", "3003559191", "3012118659", "3030413550", "3011393376", "3000148879", "3002710220", "2517506", "3005509212", "3037000637", "3003795116", "3003600763", "3002637618", "3010825766", "3006371704", "3007019572", "2432235", "1119779", "3015633428", "3002807167", "3006755541", "3004838836", "1950204", "3005862821", "3013922172", "3013646951", "3001573851", "3035708936", "3024512705", "3002671736", "3030714692", "3009129531", "3011187792", "3025376092", "3010900203", "3008514395", "3040278125", "1000113657", "3016438761", "3002821232", "3015058854", "3004032053", "3002806350", "3009288740", "3013298431", "3003902721", "3027496319", "3015347724", "3005333358", "3002808498", "3004973408", "3014840402", "1219145" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }