{ "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": "167207", "product_res_number": "Z-0354-2019", "event_date_initiated": "2018-05-24", "event_date_created": "2018-10-31", "recall_status": "Terminated", "event_date_terminated": "2022-12-08", "res_event_number": "80434", "product_code": "JQP", "product_description": "Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH\n\n The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. The system automates the process of sorting, decapping, and archiving samples. The Sorting-Drive 4.2. User Kit includes the Sorting-Drive Client software application that includes an option for manual printing of barcodes for sample tubes.", "code_info": "v4.2.1 (and 4.2, discontinued)", "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": "469-961-4941", "reason_for_recall": "Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing of barcodes.\n\nWhen printing consecutively numbered tube labels using this optional Barcode Counter function, the system incorrectly converts numbers with consecutive multiple zeroes in the middle, potentially leading to wrong barcode IDs. The firm reports this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected.", "root_cause_description": "Software change control", "action": "On 6/4/2018 Beckman Coulter (BEC) reported that the issue will be corrected via a field modification performed by Field Service. BEC reported that they do not intend to send a customer letter for this issue.US customers can contact the Technical Support Troubleshooting Hotline at (800) 854-3633.", "product_quantity": "25", "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: Algeria, Argentina, Austria, Belgium, Brazil, Chile, China, Czech Republic, Denmark ,France, Germany, Greece ,Hong Kong, India, Ireland, Israel, Italy ,Republic of Korea, Lebanon, Lithuania ,Malaysia, Netherlands, Poland, Portugal , Qatar, Romania, Russian Federation, Saudi Arabia ,South Africa , Spain, Sweden, Taiwan, Turkey , and United Kingdom.", "openfda": { "k_number": [ "K833353", "K844907", "K802471", "K780881", "K800724", "K801167", "K761063", "K861779", "K893838", "K831830", "K810968", "K790543", "K830296", "K792129", "K983468", "K821531", "K113007", "K812604", "K801438", "K760739", "K800241", "K810631", "K770671", "K871339", "K823785", "K851321", "K782052", "K802251", "K822146", "K892060", "K953652", "K820427", "K801131", "K821058", "K801091", "K864557", "K934111", "K850659", "K790336", "K801210", "K822932", "K832746", "K822381", "K821807", "K861778", "K810063", "K881194", "K792158", "K801664", "K854265", "K834490", "K861844", "K823110", "K843365", "K871853", "K834300", "K802594", "K885292", "K822860", "K831574", "K831838", "K853026", "K770877", "K803312", "K822778", "K964460", "K781217", "K923316", "K820721", "K781173", "K861412", "K832760", "K800282", "K823679", "K840502", "K842401", "K781081", "K800242" ], "registration_number": [ "3020978007", "3008789114", "3015967359", "3031570369", "9616936", "3012104009", "9710492", "3015969360", "3003618481", "3010141591", "2029302", "3002807715", "2245451", "3010258456", "3008802064", "1220649", "3004145393", "3003453957", "1061932", "3003995437", "3002889627", "1225673", "3006543086", "8043723", "3042228064", "3011194542", "9615754", "3043012074", "3011806823", "3016764932", "1810909", "3006677029", "3009542936", "2243471", "9610126", "3027486032", "3021394862", "9615507", "3012436569", "8020888", "9616530", "3010097171", "2936921", "2431530", "3043012240", "3000126629", "3009404844", "3009731198", "3013896610", "3005798890", "3042989733", "3004959793", "9610865", "3003825930", "8030392", "3009711478", "3015426626", "3023268435", "8020030", "3038419886", "3007134734", "3015738702", "3002809144", "2531491", "3017086896", "3003559191", "3012118659", "3030413550", "9614673", "1058332", "3011393376", "3000148879", "3002710220", "2517506", "3005509212", "3037000637", "3011121740", "3003795116", "3003600763", "3002637618", "3010825766", "3006371704", "2432235", "1119779", "3015633428", "3006755541", "3004838836", "1950204", "3005862821", "9610816", "3013922172", "3013646951", "3035708936", "3024512705", "3030714692", "3009129531", "3011187792", "3025376092", "3010900203", "3008514395", "3040278125", "1000113657", "3016438761", "3002821232", "3015058854", "3004032053", "3009288740", "3013298431", "3003902721", "2954323", "8043909", "3027496319", "3015347724", "3005333358", "3004973408", "3014840402", "1219145" ], "fei_number": [ "3020978007", "3008789114", "3003516723", "3015967359", "3031570369", "3010700165", "3012104009", "3015969360", "3003618481", "3010141591", "3002807715", "2245451", "3001451449", "3010258456", "3008237827", "3008802064", "1220649", "3002803444", "3004145393", "3003453957", "3003116995", "3003559576", "3003995437", "3002889627", "3006461677", "3006543086", "3042228064", "1000306472", "3011194542", "3043012074", "3000203293", "3011806823", "3016764932", "1810909", "3006677029", "3009542936", "2243471", "3002829675", "3027486032", "3021394862", "3002806559", "3012436569", "1000307651", "3010097171", "2936921", "2431530", "3043012240", "3000126629", "3009404844", "3009731198", "3013896610", "3005798890", "3042989733", "3004959793", "3003825930", "3009711478", "3015426626", "3023268435", "3038419886", "3007134734", "3003500908", "3015738702", "3002809144", "3017086896", "3003559191", "3012118659", "3030413550", "3011393376", "3000148879", "3002710220", "2517506", "3005509212", "3037000637", "3003795116", "3003600763", "3002637618", "3010825766", "3006371704", "3007019572", "2432235", "1119779", "3015633428", "3002807167", "3006755541", "3004838836", "1950204", "3005862821", "3013922172", "3013646951", "3001573851", "3035708936", "3024512705", "3002671736", "3030714692", "3009129531", "3011187792", "3025376092", "3010900203", "3008514395", "3040278125", "1000113657", "3016438761", "3002821232", "3015058854", "3004032053", "3002806350", "3009288740", "3013298431", "3003902721", "3027496319", "3015347724", "3005333358", "3002808498", "3004973408", "3014840402", "1219145" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }