{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "192442", "product_res_number": "Z-0891-2022", "event_date_initiated": "2022-03-08", "event_date_created": "2022-04-07", "recall_status": "Open, Classified", "res_event_number": "89794", "product_code": "JIS", "k_numbers": [ "K042924" ], "product_description": "ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01\n\nThe ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.", "code_info": "UDI: (01)00380740003272(17)220531(10)166000", "firm_fei_number": "1415939", "recalling_firm": "Abbott Laboratories", "address_1": "100 Abbott Park Rd Bldg Ap8b", "city": "Abbott Park", "state": "IL", "postal_code": "60064-3502", "additional_info_contact": "Suchin Song\n224-668-0343", "reason_for_recall": "This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).", "root_cause_description": "Under Investigation by firm", "action": "The firm, Abbott, notified their consignees by \"Urgent Medical Device Products Recall\" letter on 03/08/2022. The letter explained the issue and requested the use of the affected item be discontinued and destroyed, and the Customer Reply Form be completed and returned via FAX #: 1-800-777-0051 or email PMS@abbott.com. The firm is replacing the product.\n\nIf you or any of the health care providers you serve have questions regarding this \ninformation, U.S. Customers please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week).", "product_quantity": "402 kits", "distribution_pattern": "Worldwide Distribution: US (nationwide) and OUS (foreign) including countries of: AUSTRIA, BELGIUM, BOSNIA AND HERZEGOVI, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, GREECE, IRAQ, ITALY, KAZAKHSTAN, LITHUANIA, LUXEMBOURG, MACEDONIA, MOROCCO, PANAMA, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, and TURKEY", "openfda": { "k_number": [ "K821813", "K954546", "K001005", "K994325", "K922646", "K772025", "K791315", "K843110", "K022682", "K925877", "K821061", "K930477", "K871186", "K003941", "K800042", "K060266", "K813505", "K922698", "K032608", "K951629", "K841955", "K801665", "K905820", "K840220", "K840299", "K830137", "K830283", "K931834", "K921855", "K821937", "K895778", "K994114", "K010696", "K895585", "K862704", "K920809", "K821938", "K861770", "K032296", "K951585", "K910721", "K924904", "K983640", "K881693", "K840217", "K800062", "K822476", "K944701", "K871187", "K964475", "K001004", "K813478", "K905477", "K801501", "K842449", "K800206", "K861769", "K002760", "K901113", "K012878", "K855040", "K000331", "K781853", "K844581", "K994168", "K822477", "K810091", "K852068", "K823147", "K053104", "K061251", "K022901", "K822473", "K792046", "K963847", "K821934", "K871188", "K922696", "K013126", "K760806", "K032697", "K844235", "K822332", "K884168", "K813447", "K030546", "K861768", "K871185", "K921903", "K810092", "K810743", "K011568", "K872051", "K001906", "K994169", "K882726", "K780467", "K951964", "K994145", "K936201", "K842450", "K030964", "K930501", "K030320", "K870379", "K003969", "K801287", "K810963", "K940008", "K862453", "K810618", "K922699", "K822232", "K802631", "K810742", "K770072", "K820698", "K800588", "K002353", "K822474", "K861891", "K993219", "K970933", "K810867", "K001002", "K932555", "K122126", "K812861", "K810587", "K832251" ], "registration_number": [ "1181121", "1717966", "3003453957", "2250051", "3004111573", "2122870", "3011989923", "2432235", "9612316", "9710666", "2050012", "3005146313", "2050010", "3016698405", "3003749380", "1063851", "3000148879", "2431530", "8023024", "1181055", "8031673", "3008344661", "3003522182", "3004529019", "3015171822", "3013660430", "1825740", "3003561301", "3003591759", "3003539867", "1318354", "1219913", "9610126", "2434178", "3002809144", "3009518015", "3005094123", "3005625991", "2245451", "3010939897", "2084025", "3006198300", "3004192065", "9681753", "3003871639", "3007111389", "1832216", "3004493545", "9614373", "3010830834", "3003419906", "2030861", "3012471076", "2247288", "1319681", "3012963943", "1827821", "9610806", "3002642396", "1221645", "3000308930", "1319808", "1000403749", "8020316", "3005333358", "1319809", "9680746", "3002807722", "2085064", "2517506", "3037000637", "9610746", "3005529799" ], "fei_number": [ "3002806557", "1181121", "1717966", "3003453957", "3002808328", "3004111573", "2250051", "2122870", "3011989923", "2432235", "1000442352", "3005146313", "2050012", "1000122044", "3000215862", "2050010", "3016698405", "3003749380", "3000148879", "2431530", "3004525092", "1181055", "2967", "3008344661", "1000136573", "3003522182", "3015171822", "3013660430", "1000135102", "3002806809", "3003591759", "3003561301", "1318354", "1219913", "3006769061", "1825740", "2434178", "3002809144", "3009518015", "3005094123", "3005625991", "2245451", "3010939897", "2084025", "3006198300", "6387", "3004192065", "3007111389", "3003871639", "1000305841", "1832216", "3004493545", "3002808340", "3001644026", "3002806559", "3003419906", "3012471076", "3012963943", "1827821", "3003565434", "3002642396", "3000303338", "3000308930", "1221645", "1000305840", "1000403749", "3005333358", "1000206808", "3002807722", "3004529019", "2517506", "3037000637", "3005529799" ], "device_name": "Calibrator, Primary", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1150", "device_class": "2" } } ] }