{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "113627", "product_res_number": "Z-0251-2013", "event_date_initiated": "2009-11-19", "event_date_posted": "2012-11-06", "recall_status": "Terminated", "event_date_terminated": "2012-11-06", "res_event_number": "63380", "product_code": "JQP", "product_description": "Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.", "code_info": "v3.0.0_07222004 and later", "firm_fei_number": "1000306472", "recalling_firm": "Sunquest Information Systems, Inc.", "address_1": "250 S Williams Blvd", "city": "Tucson", "state": "AZ", "postal_code": "85711-4472", "additional_info_contact": "520-570-2252", "reason_for_recall": "The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.", "root_cause_description": "Nonconforming Material/Component", "action": "Sunquest sent an \"URGENT-PRODUCT SAFETY NOTICE: PSN-09-06\" letter dated November 19, 2009 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were informed that Sunquest Application Interfacing would be contacting their facility for scheduling to correct the issue.", "product_quantity": "9 units", "distribution_pattern": "Nationwide Distribution.", "openfda": { "k_number": [ "K833353", "K803312", "K871853", "K832746", "K861412", "K810631", "K823785", "K831574", "K822381", "K113007", "K821058", "K831830", "K801167", "K831838", "K861844", "K861778", "K801664", "K800242", "K822778", "K822932", "K934111", "K822860", "K844907", "K885292", "K834490", "K923316", "K802594", "K842401", "K812604", "K781081", "K760739", "K864557", "K834300", "K790336", "K781173", "K964460", "K800724", "K892060", "K881194", "K820427", "K871339", "K821807", "K810063", "K830296", "K792158", "K851321", "K802471", "K770671", "K850659", "K801210", "K823679", "K781217", "K761063", "K790543", "K823110", "K801438", "K780881", "K853026", "K832760", "K861779", "K782052", "K983468", "K953652", "K770877", "K800282", "K843365", "K802251", "K800241", "K801131", "K792129", "K821531", "K840502", "K893838", "K801091", "K810968", "K822146", "K854265", "K820721" ], "registration_number": [ "3003795116", "3043012074", "3015426626", "3002809144", "9610865", "2432235", "3031570369", "3004032053", "3005798890", "3015058854", "9610126", "3003618481", "3015633428", "3011194542", "3006543086", "3004145393", "3011806823", "3015347724", "3017086896", "3040278125", "3013896610", "3011121740", "3009404844", "3003825930", "3002637618", "2029302", "3006371704", "1810909", "3006755541", "2431530", "3004959793", "3043012240", "3027486032", "9710492", "3038419886", "3042228064", "1000113657", "3009129531", "8020888", "3005509212", "9616936", "3003600763", "3013922172", "1219145", "3016764932", "3010097171", "3010258456", "3010141591", "9615754", "3006677029", "3011393376", "3002807715", "2245451", "3009731198", "3013298431", "3042989733", "1225673", "3016438761", "3024512705", "3013646951", "2936921", "9610816", "3030413550", "1061932", "3021394862", "3037000637", "3020978007", "3009711478", "3010900203", "9615507", "1119779", "3005333358", "3023268435", "3003559191", "8030392", "3004838836", "3002710220", "1950204", "3012118659", "3003995437", "3008514395", "3011187792", "3027496319", "3003902721", "3015967359", "2243471", "3002889627", "3005862821", "8043909", "3007134734", "3009288740", "2954323", "3025376092", "3012104009", "3015738702", "3035708936", "8020030", "3010825766", "1058332", "1220649", "3008789114", "9614673", "3002821232", "3012436569", "3014840402", "2531491", "3030714692", "3009542936", "3015969360", "3004973408", "3000148879", "2517506", "9616530", "3003453957", "8043723", "3000126629", "3008802064" ], "fei_number": [ "3003795116", "3043012074", "3015426626", "3002809144", "2432235", "3031570369", "3004032053", "3005798890", "3015058854", "3003516723", "3003618481", "3015633428", "3011194542", "3006543086", "3004145393", "3011806823", "3015347724", "3017086896", "3040278125", "3013896610", "3003500908", "3009404844", "3001451449", "3003825930", "3002637618", "3006371704", "3003116995", "1810909", "3002808498", "3006755541", "3003559576", "3006461677", "2431530", "3004959793", "3002807167", "3007019572", "3001573851", "3043012240", "3027486032", "3042228064", "3038419886", "1000113657", "1000307651", "3009129531", "3005509212", "3003600763", "3013922172", "1219145", "3016764932", "3002829675", "3010097171", "3010258456", "3010141591", "3006677029", "3011393376", "3002807715", "2245451", "3009731198", "3013298431", "3042989733", "3016438761", "3024512705", "3013646951", "2936921", "3030413550", "3021394862", "3037000637", "3009711478", "3020978007", "3010900203", "1119779", "3005333358", "3023268435", "3003559191", "3004838836", "3002710220", "1950204", "3012118659", "3003995437", "3008514395", "3011187792", "3027496319", "3003902721", "3002806559", "3002671736", "3015967359", "3002806350", "3002803444", "2243471", "3002889627", "3005862821", "3007134734", "3009288740", "3025376092", "3000203293", "3012104009", "3015738702", "3035708936", "3010825766", "3008237827", "3010700165", "1220649", "3008789114", "3002821232", "3012436569", "3014840402", "3030714692", "3009542936", "3015969360", "3004973408", "3000148879", "2517506", "3003453957", "1000306472", "3000126629", "3008802064" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }