{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "110817", "product_res_number": "Z-0073-2013", "event_date_initiated": "2011-11-15", "event_date_posted": "2012-10-17", "recall_status": "Terminated", "event_date_terminated": "2012-10-19", "res_event_number": "62516", "product_code": "JQP", "product_description": "Sunquest Laboratory :\n\nintended for use by professionals working in a clinical laboratory.", "code_info": "Versions 6.4.0 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": "Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.", "root_cause_description": "Software design", "action": "Urgent - Product Safety Notice: PSN-11-06,dated, 15 November 2011, was sent to customers. Costumers should follow instructions in the notification letter. To request the software correction, create a Case via the Client Support webpage at: www.sunquestinfo.com/supportweb.\n\nReturn receipt acknowledging PSN-11-06 is required .\n\nClient Support can be reached at 1-877-239-6337 for U.S. and Canadian sites and at +44 (0) 161 335 0562 for International sites.", "product_quantity": "127 sites", "distribution_pattern": "Nationwide distribution", "openfda": { "k_number": [ "K861778", "K822932", "K781081", "K761063", "K803312", "K801167", "K893838", "K823679", "K801210", "K792158", "K790543", "K881194", "K871853", "K810631", "K964460", "K832746", "K790336", "K801091", "K840502", "K792129", "K781173", "K830296", "K780881", "K822778", "K885292", "K983468", "K802471", "K113007", "K834300", "K823785", "K760739", "K810063", "K770671", "K871339", "K800241", "K832760", "K923316", "K851321", "K831838", "K822381", "K861779", "K801438", "K782052", "K833353", "K934111", "K831574", "K770877", "K823110", "K800242", "K820427", "K800282", "K861844", "K842401", "K802251", "K800724", "K802594", "K821807", "K892060", "K820721", "K812604", "K801664", "K821531", "K831830", "K801131", "K834490", "K821058", "K864557", "K953652", "K822860", "K781217", "K810968", "K854265", "K843365", "K822146", "K861412", "K850659", "K844907", "K853026" ], "registration_number": [ "3013896610", "2432235", "3021394862", "3010900203", "3013298431", "3002809144", "2954323", "3009731198", "3005862821", "3037000637", "3043012240", "3014840402", "3010097171", "3009129531", "3006371704", "3004032053", "3005509212", "9615507", "3040278125", "3043012074", "2517506", "3013922172", "3011194542", "3020978007", "8043909", "3004959793", "3003795116", "3015633428", "9610865", "9610816", "3009288740", "9614673", "3003902721", "3023268435", "3007134734", "3025376092", "2531491", "3003559191", "3006755541", "9615754", "3030413550", "3002637618", "3005798890", "3042228064", "3002821232", "3008802064", "3035708936", "3003453957", "1061932", "1119779", "3015738702", "3009542936", "3031570369", "3042989733", "8020888", "3002807715", "9616530", "3005333358", "1220649", "3012436569", "3010825766", "1810909", "3015426626", "1000113657", "8043723", "3017086896", "9710492", "3004973408", "8020030", "3008514395", "3000126629", "3027496319", "9610126", "3004145393", "3006677029", "2936921", "3003618481", "3009711478", "2243471", "3003825930", "3009404844", "3003995437", "8030392", "3011187792", "3010258456", "3002889627", "3015969360", "3015347724", "3027486032", "3006543086", "3016764932", "1058332", "9616936", "2431530", "1219145", "1225673", "2245451", "3008789114", "2029302", "3030714692", "3024512705", "3038419886", "3012104009", "3016438761", "3012118659", "3015967359", "3002710220", "3015058854", "3013646951", "3000148879", "3011121740", "3010141591", "3011393376", "1950204", "3011806823", "3004838836", "3003600763" ], "fei_number": [ "3013896610", "2432235", "3021394862", "3010900203", "3013298431", "3002809144", "3009731198", "3005862821", "3037000637", "3043012240", "3002808498", "3008237827", "3014840402", "3010097171", "3009129531", "3006371704", "3004032053", "3005509212", "3040278125", "3043012074", "2517506", "3013922172", "3011194542", "3020978007", "3002671736", "3002807167", "3004959793", "3003795116", "3006461677", "3015633428", "3009288740", "3023268435", "3003902721", "3007134734", "3025376092", "3003559191", "3006755541", "3030413550", "3002637618", "3001573851", "3005798890", "3003559576", "3042228064", "3002821232", "3008802064", "3035708936", "3001451449", "3003453957", "3003500908", "1119779", "3015738702", "1000307651", "3009542936", "3031570369", "3042989733", "3002807715", "3005333358", "1220649", "3012436569", "3010825766", "3007019572", "1810909", "3002806350", "3015426626", "3002806559", "1000113657", "3000203293", "3017086896", "3003516723", "3004973408", "3008514395", "3000126629", "3027496319", "3002829675", "3004145393", "3006677029", "2936921", "3003618481", "3002803444", "3009711478", "2243471", "3003116995", "3003825930", "3009404844", "3003995437", "3011187792", "3010258456", "3002889627", "3015969360", "3015347724", "3027486032", "3006543086", "3016764932", "2431530", "1219145", "2245451", "3008789114", "3030714692", "3024512705", "3038419886", "3012104009", "3016438761", "1000306472", "3012118659", "3015967359", "3002710220", "3015058854", "3013646951", "3010700165", "3000148879", "3010141591", "3011393376", "1950204", "3011806823", "3004838836", "3003600763" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }