{ "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": "29968", "product_res_number": "Z-0091-04", "event_date_initiated": "2003-09-30", "event_date_posted": "2004-07-20", "recall_status": "Terminated", "event_date_terminated": "2004-04-07", "res_event_number": "27495", "product_code": "JQP", "k_numbers": [ "K980367" ], "product_description": "AEROSET System Software version 1.02ER000", "code_info": "Catalog 2-95068-01 AEROSET System Software 1.02ER000 and Catalog 2-95175-01 AEROSET System Software 1.02ER000 Upgrade Kit", "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": "75015-2020", "reason_for_recall": "Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.", "root_cause_description": "Other", "action": "The firm issued a letter on 09/30/2003 notifying customers of the Device Correction and provided instructions to disable the audible alert. Abbott Diagnostics will correct this issue in the next revision of the AEROSET System Software.", "product_quantity": "133", "distribution_pattern": "Nationwide and to the following foreign countries: Norway, United Kingdom, Hong Kong, United Arab Emirates, Canada, New Zealand, and China", "openfda": { "k_number": [ "K861778", "K822932", "K781081", "K761063", "K803312", "K801167", "K893838", "K823679", "K801210", "K792158", "K790543", "K881194", "K871853", "K810631", "K964460", "K832746", "K790336", "K801091", "K840502", "K792129", "K781173", "K830296", "K780881", "K822778", "K885292", "K983468", "K802471", "K113007", "K834300", "K823785", "K760739", "K810063", "K770671", "K871339", "K800241", "K832760", "K923316", "K851321", "K831838", "K822381", "K861779", "K801438", "K782052", "K833353", "K934111", "K831574", "K770877", "K823110", "K800242", "K820427", "K800282", "K861844", "K842401", "K802251", "K800724", "K802594", "K821807", "K892060", "K820721", "K812604", "K801664", "K821531", "K831830", "K801131", "K834490", "K821058", "K864557", "K953652", "K822860", "K781217", "K810968", "K854265", "K843365", "K822146", "K861412", "K850659", "K844907", "K853026" ], "registration_number": [ "3013896610", "2432235", "3021394862", "3010900203", "3013298431", "3002809144", "2954323", "3009731198", "3005862821", "3037000637", "3043012240", "3014840402", "3010097171", "3009129531", "3006371704", "3004032053", "3005509212", "9615507", "3040278125", "3043012074", "2517506", "3013922172", "3011194542", "3020978007", "8043909", "3004959793", "3003795116", "3015633428", "9610865", "9610816", "3009288740", "9614673", "3003902721", "3023268435", "3007134734", "3025376092", "2531491", "3003559191", "3006755541", "9615754", "3030413550", "3002637618", "3005798890", "3042228064", "3002821232", "3008802064", "3035708936", "3003453957", "1061932", "1119779", "3015738702", "3009542936", "3031570369", "3042989733", "8020888", "3002807715", "9616530", "3005333358", "1220649", "3012436569", "3010825766", "1810909", "3015426626", "1000113657", "8043723", "3017086896", "9710492", "3004973408", "8020030", "3008514395", "3000126629", "3027496319", "9610126", "3004145393", "3006677029", "2936921", "3003618481", "3009711478", "2243471", "3003825930", "3009404844", "3003995437", "8030392", "3011187792", "3010258456", "3002889627", "3015969360", "3015347724", "3027486032", "3006543086", "3016764932", "1058332", "9616936", "2431530", "1219145", "1225673", "2245451", "3008789114", "2029302", "3030714692", "3024512705", "3038419886", "3012104009", "3016438761", "3012118659", "3015967359", "3002710220", "3015058854", "3013646951", "3000148879", "3011121740", "3010141591", "3011393376", "1950204", "3011806823", "3004838836", "3003600763" ], "fei_number": [ "3013896610", "2432235", "3021394862", "3010900203", "3013298431", "3002809144", "3009731198", "3005862821", "3037000637", "3043012240", "3002808498", "3008237827", "3014840402", "3010097171", "3009129531", "3006371704", "3004032053", "3005509212", "3040278125", "3043012074", "2517506", "3013922172", "3011194542", "3020978007", "3002671736", "3002807167", "3004959793", "3003795116", "3006461677", "3015633428", "3009288740", "3023268435", "3003902721", "3007134734", "3025376092", "3003559191", "3006755541", "3030413550", "3002637618", "3001573851", "3005798890", "3003559576", "3042228064", "3002821232", "3008802064", "3035708936", "3001451449", "3003453957", "3003500908", "1119779", "3015738702", "1000307651", "3009542936", "3031570369", "3042989733", "3002807715", "3005333358", "1220649", "3012436569", "3010825766", "3007019572", "1810909", "3002806350", "3015426626", "3002806559", "1000113657", "3000203293", "3017086896", "3003516723", "3004973408", "3008514395", "3000126629", "3027496319", "3002829675", "3004145393", "3006677029", "2936921", "3003618481", "3002803444", "3009711478", "2243471", "3003116995", "3003825930", "3009404844", "3003995437", "3011187792", "3010258456", "3002889627", "3015969360", "3015347724", "3027486032", "3006543086", "3016764932", "2431530", "1219145", "2245451", "3008789114", "3030714692", "3024512705", "3038419886", "3012104009", "3016438761", "1000306472", "3012118659", "3015967359", "3002710220", "3015058854", "3013646951", "3010700165", "3000148879", "3010141591", "3011393376", "1950204", "3011806823", "3004838836", "3003600763" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }