{ "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": "189277", "product_res_number": "Z-0033-2022", "event_date_initiated": "2021-07-29", "event_date_created": "2021-10-06", "recall_status": "Terminated", "event_date_terminated": "2023-07-24", "res_event_number": "88680", "product_code": "JIS", "product_description": "Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.", "code_info": "Lot 00681Y600", "firm_fei_number": "3000303338", "recalling_firm": "Sentinel CH SpA", "address_1": "Via Robert Koch 2 2 via robert koch", "city": "Milan", "country": "Italy", "additional_info_contact": "Customer Service Department\n+39 02 345 5141", "reason_for_recall": "Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.", "root_cause_description": "Under Investigation by firm", "action": "Firm notified distributor July 29, 2021, and provided an Urgent Field Safety Notice letter to be forwarded to final end users on August 20, 2021.\n\nCustomers were advised to do the following: \n\n- Immediately discontinue use of affected lot of calibrator\n- Destroy any remaining inventory of affected lot according to your laboratory procedures\n- Contact Abbott to order replacement material\n- Review the content of the communication with your Medical Director\n- Retain the letter for future reference\n\nPlease forward notification to all individuals in your organization who need to be aware, or to any individuals or organizations where the recalled lot was transferred.\n\nIf you have questions regarding this recall, please contact your local area Customer Service.", "product_quantity": "32", "distribution_pattern": "US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.", "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" } } ] }