{ "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": "105257", "product_res_number": "Z-0261-2012", "event_date_initiated": "2011-08-08", "event_date_posted": "2011-11-21", "recall_status": "Terminated", "event_date_terminated": "2013-11-22", "res_event_number": "60405", "product_code": "JQP", "product_description": "Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. \n\nSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.", "code_info": "Versions: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x.", "firm_fei_number": "1000307651", "recalling_firm": "SCC Soft Computer", "address_1": "5400 Tech Data Drive", "city": "Clearwater", "state": "FL", "postal_code": "33760", "additional_info_contact": "Kathryn Branca\n727-789-0100", "reason_for_recall": "On 08/08/2011 SCC Soft Computer, Clearwater, FL initiated a correction on following SoftLab used with: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. A client reported a flagging error where the result was flagged as critical in the Instrument Menu but the printed report did not show the corresponding flag. All affected clients were notified of the issue on 0", "root_cause_description": "Software design", "action": "SCC Soft Computer notified all affected customers on August 8, 2011, of the recall via the SCC Soft Computer proprietary Task management system to manage client communication. Clients use this tool to log in requests for services and receive and provide updates to any issue. \n\nEach client user has a unique password and every action is date and time-stamped. Each Task has a unique identifier and a full audit trail.\n\nSCC recommended to the customer until Live on the correction avoid making edits in the instrument menu.\n\nFor further questions please call (727) 789-0100.", "product_quantity": "255", "distribution_pattern": "Worldwide Distribution - USA ( nationwide) and Canada.", "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" } } ] }