{ "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": "173179", "product_res_number": "Z-1982-2019", "event_date_initiated": "2018-09-17", "event_date_created": "2019-07-17", "recall_status": "Terminated", "res_event_number": "82919", "product_code": "JQP", "product_description": "Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices:\n\n(A) Kaluza C Perpetual License\n(B) Kaluza C Single Use 1 Year License\n(C) Kaluza C 5 User Network\n(D) Kaluza C 10 User Network\n(E) Kaluza C Perpetual Educational License\n(F) Kaluza C Single User 1 Year educational License\n(G) Kaluza C 10 User Network Educational License\n(H) Kaluza C 5 User Network Educational License\n(I) Kaluza C Flow Cytometry Software", "code_info": "A. C10574/UDI: 15099590705084 B. C10575/UDI: 15099590705091 C. C10576/UDI: 15099590705114 D. C10577/UDI: 15099590705107 E. C10578/UDI: 15099590705121 F. C10579/UDI: 15099590705138 G. C10580/UDI: 15099590705145 H. C10581/UDI: 15099590705152 I. C21166/UDI: 15099590705169", "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": "Nancy Nadler\n469-961-4941", "reason_for_recall": "Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting results.", "root_cause_description": "Software Manufacturing/Software Deployment", "action": "An \"Urgent Medical Device Recall\" letter was sent on September 18, 2018 via email to all affected customers. Beckman Coulter ask that if you are using a LIS, please review all previous LIS transmissions which included keywords for accuracy by comparing keywords displayed in Kaluza C Information Plots to those in the LIS system. Please report any erroneous transmissions to Beckman Coulter. \n\nThe recall letter also ask their customers to visit the Beckman Coulter website to download version Kaluza C 1.1 and install on all affected systems. Installation of Kaluza C version 1.1 will prevent software crashes and result in proper keyword value being transmitted for all samples\n\n1. Navigate to http://www.kaluzasoftware.com and click the \"Download\" icon.\n2. Click \"Download Kaluza C1.1\" and fill in the requested information.\n3. Click the link in the registration email to download Kaluza C version 1.1.\n4. Install Kaluza C version 1.1 on systems used for analysis. \n\n If you have questions regarding the notification, please contact 1-800-369-0333.", "product_quantity": "41 units", "distribution_pattern": "US: CA and NY\nOUS: United Kingdom, Switzerland and Germany", "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" } } ] }