{ "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": "105440", "product_res_number": "Z-0444-2012", "event_date_initiated": "2011-07-26", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2013-05-21", "res_event_number": "60455", "product_code": "JQP", "product_description": "SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32.\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": "SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32.", "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": "SCC Soft Computer, Clearwater, FL, initiated a correction for the SoftLab used with SA INST. A test performed on the Roche Cobas Integra series of instruments when used with the GenInst/Dispatch listening program could cause incorrect flagging for a test result posted to the lab database.", "root_cause_description": "Software design", "action": "The firm, SCC Soft Computer, sent a \"Correction Communication\" letter on July 26, 2011 to customers/consignees. The letter describes the product problem and actions to be taken. The firm will correct the software to recognize and support all known formats of the resulting date and time sent by an instrument. The software is available via a recommended patch or hot fix to the client's current release. The customers were asked to acknowledge receipt of the task and grant permission for SCC to correct the affected configuration files. \n\nIf you have any questions, call (727) 789-0100.", "product_quantity": "265", "distribution_pattern": "Worldwide Distribution - USA (Nationwide) and Country of: Canada.", "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" } } ] }