{ "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": "48601", "product_res_number": "Z-0023-2007", "event_date_initiated": "2006-09-07", "event_date_posted": "2006-10-12", "recall_status": "Terminated", "event_date_terminated": "2011-09-09", "res_event_number": "36405", "product_code": "JIS", "k_numbers": [ "K935612" ], "product_description": "Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.", "code_info": "Lot# 33266Q100 Expiration Date 11/04/2006", "firm_fei_number": "2623532", "recalling_firm": "Abbott Diagnostic International, Ltd.", "address_1": "Carr 2 Km 58.0 Cruce Davila", "city": "Barceloneta", "state": "PR", "postal_code": "00617-3009", "reason_for_recall": "Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.", "root_cause_description": "Other", "action": "The Device Recall Letter dated September 07, 2006, and Customer Reply Form was sent via Federal Express Priority mail to all customers who received the affected lots.", "product_quantity": "797", "distribution_pattern": "Worldwide, including USA, Puerto Rico, Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, Honduras, Trinidad-Tobago, St. Vincent, Bahamas, Panama, and Cayman Islands.", "openfda": { "k_number": [ "K001005", "K770072", "K791315", "K813505", "K060266", "K822474", "K861891", "K964475", "K921855", "K122126", "K881693", "K963847", "K810587", "K924904", "K001002", "K921903", "K002760", "K920809", "K823147", "K000331", "K822476", "K861768", "K810618", "K895778", "K843110", "K800206", "K821934", "K032697", "K813447", "K844235", "K001004", "K822477", "K801665", "K922646", "K821937", "K802631", "K812861", "K772025", "K820698", "K821813", "K951585", "K822332", "K895585", "K983640", "K780467", "K905820", "K901113", "K936201", "K840217", "K022901", "K053104", "K800588", "K861770", "K801501", "K010696", "K951629", "K940008", "K852068", "K925877", "K870379", "K954546", "K801287", "K882726", "K001906", "K810963", "K994114", "K013126", "K830283", "K930501", "K821061", "K871186", "K842449", "K002353", "K871187", "K922696", "K832251", "K792046", "K994169", "K871185", "K841955", "K932555", "K922698", "K030546", "K930477", "K822473", "K861769", "K760806", "K844581", "K810743", "K862453", "K970933", "K810091", "K944701", "K840220", "K810867", "K922699", "K842450", "K822232", "K800062", "K840299", "K871188", "K813478", "K003969", "K872051", "K905477", "K910721", "K821938", "K862704", "K022682", "K994145", "K800042", "K884168", "K030320", "K994168", "K993219", "K030964", "K951964", "K003941", "K061251", "K830137", "K855040", "K994325", "K032296", "K810092", "K012878", "K032608", "K931834", "K781853", "K011568", "K810742" ], "registration_number": [ "3003522182", "2050012", "3004493545", "3012963943", "9612316", "3011989923", "9614373", "3004192065", "1319681", "1221645", "3015171822", "3013660430", "3004111573", "9680746", "3003749380", "1319808", "2050010", "3002809144", "3003419906", "2084025", "9610806", "3009518015", "3005094123", "3004529019", "3003561301", "3005625991", "9610126", "2245451", "3003591759", "2250051", "3010830834", "8031673", "8023024", "1825740", "3005146313", "1717966", "1063851", "1827821", "3000148879", "9610746", "2517506", "9710666", "3037000637", "9681753", "3002807722", "8020316", "3016698405", "3012471076", "1219913", "1319809", "2030861", "3007111389", "3003453957", "3002642396", "3005333358", "2434178", "2431530", "1181055", "1000403749", "3003871639", "2432235", "2247288", "1181121", "1318354", "3008344661", "3000308930", "3006198300", "2122870", "2085064", "3003539867", "3005529799", "1832216", "3010939897" ], "fei_number": [ "3003522182", "1000135102", "2050012", "3004493545", "3002808328", "3012963943", "3011989923", "3004192065", "1221645", "3015171822", "3013660430", "3002808340", "3004111573", "3000303338", "3003749380", "1000305840", "2050010", "3002809144", "3003419906", "2084025", "3004525092", "3009518015", "3005094123", "3003565434", "3003561301", "3004529019", "3005625991", "2250051", "2245451", "3002806809", "2967", "3003591759", "3005146313", "1825740", "1717966", "1827821", "3000148879", "3002806559", "2517506", "3037000637", "3002807722", "1219913", "3002806557", "3016698405", "3006769061", "3012471076", "1000136573", "1000305841", "3000215862", "6387", "3007111389", "3003453957", "3002642396", "3001644026", "1000206808", "3005333358", "2434178", "2431530", "1181055", "1000403749", "3003871639", "2432235", "1181121", "1318354", "3008344661", "3000308930", "3006198300", "1000442352", "2122870", "3005529799", "1832216", "3010939897", "1000122044" ], "device_name": "Calibrator, Primary", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1150", "device_class": "2" } } ] }