{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "161071", "product_res_number": "Z-1169-2018", "event_date_initiated": "2018-01-19", "event_date_created": "2018-03-22", "recall_status": "Completed", "res_event_number": "79006", "product_code": "JQP", "product_description": "AutoMate 1200 Catalog Number ODL25120;\nAutoMate 1250 Catalog Number ODL25125;\nAutoMate 2500 Catalog Number ODL25250;\nAutoMate 2550 Catalog Number ODL25255", "code_info": "All systems up to the following Serial Numbers: ODL25120 Revision T; SN3101, ODL25125 Revision W; SN1508, ODL25250 Revision T; SN2416, ODL25255 Revision W; SN4617", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "250 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6232", "additional_info_contact": "Customer Service\n469-961-4941", "reason_for_recall": "Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination.", "root_cause_description": "Device Design", "action": "Beckman Coulter plans to replace the belt via Service Modification during the next planned service maintenance visit. At that time, the customer will be informed of the belt replacement by the service engineer.", "product_quantity": "98 units in the US", "distribution_pattern": "Australia, Austria, Belarus,\nBelgium, Bosnia and Herzegovina, Brazil,\nCanada, China, Croatia,\nCyprus, Czech Republic, Denmark,\nFinland, France, Germany,\nGibraltar, Greece, Hong Kong,\nHungary, India, Ireland,\nIsrael, Italy, Korea,\nKuwait, Latvia, Lithuania,\nMacao, Mayotte, Mexico,\nNetherlands, New Zealand, Norway,\nPanama, Poland, Portugal,\nQatar, Russia, Saudi Arabia,\nSingapore, Slovakia, Slovenia,\nSouth Africa, Spain, Sweden,\nSwitzerland, Taiwan, Turkey,\nUnited Kingdom, United States", "openfda": { "k_number": [ "K851321", "K834490", "K802251", "K781081", "K832746", "K834300", "K831838", "K844907", "K853026", "K861778", "K782052", "K871339", "K831574", "K885292", "K842401", "K800724", "K770671", "K822932", "K801167", "K781173", "K861844", "K831830", "K822860", "K822146", "K832760", "K802471", "K801438", "K792129", "K823679", "K113007", "K810063", "K760739", "K861779", "K821531", "K802594", "K892060", "K833353", "K821807", "K801210", "K801131", "K790543", "K812604", "K821058", "K830296", "K770877", "K803312", "K800282", "K801664", "K820721", "K964460", "K823110", "K953652", "K801091", "K790336", "K864557", "K822381", "K800242", "K822778", "K780881", "K820427", "K893838", "K810968", "K854265", "K871853", "K843365", "K850659", "K983468", "K761063", "K792158", "K923316", "K810631", "K781217", "K823785", "K800241", "K840502", "K881194", "K861412", "K934111" ], "registration_number": [ "2531491", "3003559191", "1219145", "2954323", "3014840402", "3015633428", "3023268435", "3042989733", "3011187792", "3008802064", "3027496319", "3005798890", "3010258456", "3035708936", "3010900203", "3002889627", "3008789114", "9610126", "3012118659", "3004032053", "3037000637", "2517506", "2029302", "3015967359", "3005862821", "3025376092", "3013922172", "3015426626", "3013298431", "1225673", "3011121740", "9610816", "9615507", "3011806823", "3040278125", "9614673", "3013646951", "3009129531", "1220649", "2432235", "3016764932", "9610865", "3027486032", "3043012240", "3015969360", "8030392", "8020888", "9710492", "3015347724", "3004959793", "3006543086", "3003902721", "2243471", "9616936", "3003825930", "3008514395", "3002821232", "3003600763", "3006677029", "3015058854", "3003795116", "3015738702", "3009731198", "3020978007", "3004838836", "3003453957", "3038419886", "3002809144", "3021394862", "9615754", "2245451", "3043012074", "3009542936", "1119779", "3004145393", "3006371704", "1058332", "3013896610", "3010141591", "3031570369", "3030714692", "3004973408", "3024512705", "3042228064", "3005509212", "8020030", "2431530", "9616530", "3030413550", "3012436569", "3009288740", "3011194542", "3003618481", "3007134734", "1810909", "8043909", "3002807715", "2936921", "3010097171", "3002710220", "3002637618", "1950204", "3011393376", "3000126629", "3009404844", "3000148879", "3010825766", "3016438761", "1061932", "3003995437", "3017086896", "3009711478", "3012104009", "8043723", "1000113657", "3005333358", "3006755541" ], "fei_number": [ "3003559191", "1219145", "3014840402", "3015633428", "3023268435", "3042989733", "3011187792", "3008802064", "3027496319", "3005798890", "3010258456", "3035708936", "3010900203", "3002889627", "3008789114", "3012118659", "3004032053", "3003559576", "3037000637", "2517506", "3003500908", "3000203293", "3015967359", "3005862821", "3002806559", "3013922172", "3025376092", "3015426626", "1000307651", "3013298431", "3011806823", "3040278125", "3013646951", "3009129531", "1220649", "2432235", "3016764932", "3027486032", "3043012240", "3015969360", "3015347724", "3004959793", "3006543086", "3003902721", "2243471", "3003825930", "3008514395", "3003600763", "3002821232", "3006677029", "3015058854", "3003795116", "3015738702", "3009731198", "3008237827", "3020978007", "3004838836", "3003453957", "3038419886", "3002809144", "3021394862", "3002808498", "2245451", "3043012074", "3009542936", "3006461677", "1119779", "3004145393", "3006371704", "3013896610", "3010141591", "3031570369", "3002671736", "3002807167", "3030714692", "3004973408", "3024512705", "3042228064", "3005509212", "3001573851", "2431530", "3030413550", "3012436569", "3009288740", "3011194542", "3003618481", "3007134734", "1810909", "3007019572", "3002807715", "2936921", "3010097171", "3002710220", "3002637618", "1950204", "3011393376", "3002829675", "3000126629", "3010700165", "3009404844", "3000148879", "3010825766", "3016438761", "3003995437", "3017086896", "3009711478", "3001451449", "3012104009", "1000113657", "3003516723", "3005333358", "3003116995", "3006755541", "3002803444", "3002806350", "1000306472" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }