{ "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": "72843", "product_res_number": "Z-0214-2009", "event_date_initiated": "2008-08-01", "event_date_posted": "2008-11-12", "recall_status": "Terminated", "event_date_terminated": "2011-11-28", "res_event_number": "49136", "product_code": "JQP", "product_description": "Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3.\n\nThe system is marketed as an automated solution for managing laboratory processes including: 1) Patient registration, 2) Order entry and order modification, 3) Specimen collection, verification, suitability, and distribution, 4) Quality assurance checking, 5) Workload recording, 6) Billing charge capture, 7) Standards and controls recording, 8) Test order result inquiry and reporting, 9) Organism susceptibility and epidemiology records, 10) Microbiology culture direct examination and observation recording, 11) Outreach clients, specimens, and results, 12) Client-specific reporting capabilities, 13) Inbound client service request tracking, and 14) Historical data.", "code_info": "Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3.", "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": "While performing in-house testing for the Sunquest Laboratory System and under certain conditions, there have been instances in which an error that occurred at the database level or originated in the operating system (Cache)was not communicated or displayed in the Graphic User\nInterface (GUI) application so the activity continued. While this error was registered in the error log in the System\nU", "root_cause_description": "Software design", "action": "A notice (PSN-08-07) was issued to all customers on 08/01/2008 via e-mail. The notice advises customers of the problem and actions Sunquest Information Systems has taken to eliminate the Problem. Sunquest Client Support will contact their facility to schedule correcting the error trap setting. The notice also provides temporary procedural instructions to include monitoring error log using System Utilities (Function UTL) and suboption 2, System Error/Message Inquiry. Contact Client Support at 520-570-2252 for questions or additional information.", "product_quantity": "139", "distribution_pattern": "Worldwide Distribution including USA and countries of Canada, Denmark, Saudi Arabia and United Arab Emirates.", "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" } } ] }