{ "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": "49668", "product_res_number": "Z-0471-2007", "event_date_initiated": "2006-11-01", "event_date_posted": "2007-01-09", "recall_status": "Terminated", "event_date_terminated": "2012-02-27", "res_event_number": "36958", "product_code": "JQP", "product_description": "Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers", "code_info": "all codes with the Software version", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc", "address_1": "200 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92822-6208", "additional_info_contact": "Nora Zerounian\n714-961-3634", "reason_for_recall": "The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. This issue is limited to only protocols utilizing the Ratio parameter.", "root_cause_description": "Other", "action": "A Product corrective Action (PCA) letter was mailed on 11/1/06 to Expo 32 software accounts. They are informed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialogue box is accessed. The issue is limited to only protocols utilizing the Ratio parameter. An immediate user preventive action to remedy this issue each time acquisition of samples that require a protocol utilizing the ratio parameter is desired is given within the letter: 1) Perform acquisition of samples in batches which use protocols containing the same ratio parameter assignments. 2) Before running samples, open the protocol intended for use and open the Parameter Selection dialog box to ensure the correct ratio parameter assignments for numerator and denominator are selected. Make any necessary changes and save the protocol. 3) Run samples. (Letter was sent by US mail). A response form is included.", "product_quantity": "28 units", "distribution_pattern": "Nationwide including the states of MA, AL, CO, MI, IN, MD, MO NY, PA, TX, AR, CA, NJ, FL, and TN", "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" } } ] }