{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "176252", "product_res_number": "Z-0492-2020", "event_date_initiated": "2018-11-09", "event_date_created": "2019-11-18", "recall_status": "Open, Classified", "res_event_number": "83732", "product_code": "JQP", "product_description": "AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 \nAutomate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255", "code_info": "All units containing software Version(s) 4.1.1 and up", "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": "Beckman Coulter Customer Service\n800-526-3821", "reason_for_recall": "Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection time-out occurred between the system and Laboratory Information System (LIS) .", "root_cause_description": "Other", "action": "A \"Urgent Medical device Recall\" letter was sent to affected consignees on November 9, 2018 via USPS. The letter informed consignees of the following:\n\n\n1. If you are using the MTP kit option of the AutoMate 2500 Family systems, please ensure\nthat your system meets the required software prerequisites stated in the Issue section.\n\" If the requirements are met, you can safely continue using your system.\n\" If the requirements are not met;\n\nPermanently discontinue using the MTP kit option\nor\nContact your Beckman Coulter representative to upgrade your system to meet the required software prerequisites.\n\n2. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation.\n\n3. If you are a centralized license holder, please provide the other affected laboratories of your\norganization or association with a copy of this letter.\n\n5. Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication.\n\n6. If you have any questions regarding this notice, please contact Beckman Coulter via: http://www.beckmancoulter.com; \n by phone (800) 526-3821, or your local Beckman Coulter representative.", "product_quantity": "83 automate systems", "distribution_pattern": "US: NY, VA\n\nOUS:\nAustria Belgium Czech Republic\nFrance Germany Israel\nItaly Lithuania Mayotte\nRomania Slovakia South Africa\nSpain Sweden Switzerland\nUnited Kingdom", "openfda": { "k_number": [ "K861412", "K802251", "K801091", "K800241", "K821531", "K810968", "K802594", "K800282", "K810063", "K893838", "K983468", "K854265", "K790543", "K801131", "K760739", "K964460", "K820721", "K831838", "K871853", "K822778", "K822146", "K810631", "K802471", "K885292", "K781173", "K822860", "K853026", "K861844", "K790336", "K831830", "K840502", "K844907", "K822381", "K781081", "K770877", "K871339", "K832746", "K934111", "K842401", "K822932", "K953652", "K792158", "K801167", "K823785", "K834490", "K770671", "K761063", "K800724", "K832760", "K781217", "K801210", "K843365", "K821807", "K113007", "K780881", "K823110", "K861779", "K861778", "K823679", "K803312", "K812604", "K792129", "K801664", "K923316", "K851321", "K800242", "K831574", "K834300", "K864557", "K850659", "K892060", "K782052", "K830296", "K821058", "K833353", "K820427", "K801438", "K881194" ], "registration_number": [ "2243471", "3007134734", "3002807715", "8030392", "2954323", "3003825930", "3015738702", "3012118659", "8043723", "3010097171", "3040278125", "9610126", "3002889627", "3017086896", "9615507", "1220649", "3031570369", "1950204", "3011121740", "1119779", "3002637618", "3008789114", "3003453957", "3023268435", "3009129531", "3004838836", "3003559191", "3011393376", "2517506", "3042228064", "9614673", "3003795116", "1058332", "3004032053", "3005862821", "3024512705", "3003618481", "3009288740", "9610865", "3010258456", "9616530", "1061932", "3025376092", "9710492", "8020888", "3011806823", "3011187792", "3006543086", "3015347724", "3010900203", "3035708936", "3015426626", "3005798890", "3021394862", "1225673", "2245451", "3013298431", "3014840402", "3043012074", "3009731198", "3016438761", "1000113657", "3012104009", "3015967359", "2936921", "3015633428", "3043012240", "9610816", "3005509212", "3013896610", "3009542936", "3000126629", "2431530", "3037000637", "3027486032", "3042989733", "3005333358", "3012436569", "1219145", "3004973408", "3008802064", "8020030", "3000148879", "3013922172", "2432235", "3015058854", "3011194542", "3002809144", "3020978007", "9616936", "1810909", "2531491", "3009404844", "3030413550", "3006677029", "3003600763", "3030714692", "3002710220", "3008514395", "9615754", "3010141591", "3002821232", "3006371704", "3006755541", "3010825766", "3003995437", "3003902721", "3013646951", "3015969360", "3038419886", "8043909", "3027496319", "3004145393", "3009711478", "3004959793", "3016764932", "2029302" ], "fei_number": [ "2243471", "3007134734", "3002807715", "3002806350", "3003825930", "3015738702", "3010700165", "3012118659", "3010097171", "3040278125", "3002889627", "3017086896", "3031570369", "1220649", "1950204", "1000306472", "1119779", "3002637618", "3008789114", "1000307651", "3003453957", "3023268435", "3009129531", "3004838836", "3003559191", "3011393376", "2517506", "3042228064", "3002671736", "3003795116", "3004032053", "3005862821", "3024512705", "3003618481", "3009288740", "3002829675", "3001573851", "3010258456", "3025376092", "3007019572", "3002807167", "3003559576", "3011806823", "3011187792", "3006543086", "3015347724", "3010900203", "3035708936", "3015426626", "3005798890", "3021394862", "2245451", "3013298431", "3014840402", "3043012074", "3009731198", "3016438761", "1000113657", "3012104009", "3006461677", "3015967359", "2936921", "3015633428", "3002808498", "3043012240", "3001451449", "3005509212", "3013896610", "3009542936", "3000126629", "2431530", "3037000637", "3027486032", "3042989733", "3005333358", "3012436569", "1219145", "3004973408", "3003500908", "3003116995", "3002803444", "3008802064", "3000148879", "3013922172", "2432235", "3015058854", "3011194542", "3002809144", "3020978007", "3000203293", "1810909", "3003516723", "3009404844", "3030413550", "3002806559", "3006677029", "3003600763", "3030714692", "3002710220", "3008237827", "3008514395", "3010141591", "3002821232", "3006371704", "3006755541", "3010825766", "3003995437", "3003902721", "3013646951", "3015969360", "3038419886", "3027496319", "3004145393", "3009711478", "3004959793", "3016764932" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }