{ "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": "150710", "product_res_number": "Z-0407-2017", "event_date_initiated": "2016-10-24", "event_date_created": "2016-11-15", "recall_status": "Terminated", "event_date_terminated": "2018-02-01", "res_event_number": "75526", "product_code": "JIS", "k_numbers": [ "K994278" ], "product_description": "Access Ostase Calibrators, Catalog No. 37305, B83876\n\nProduct Usage:\nThe Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.", "code_info": "623207 626000 628294 628296", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "250 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6232", "reason_for_recall": "Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.", "root_cause_description": "Under Investigation by firm", "action": "Beckman Coulter sent an Urgent Medical Device Recall letter dated October 24, 2016 was sent to all their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions regarding the notice are instructed to contact Customer Technical Support Center at http://www.beckmancoulter.com, (800) 854-3633 in US and Canada, and to contact local Beckman Coulter representative if outside of US and Canada.", "product_quantity": "357 kits total (94 kits in US)", "distribution_pattern": "US Nationwide Distribution in the states of: UT, MI, MA, LA, IN, NC, CA, TX, NJ, IL, WI, MN, FL, KA, NY, CO, WA, KY, VA, and AL.\n\nAffected geographies: Belgium, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Mexico, Philippines, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan.", "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" } } ] }