{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "82110", "product_res_number": "Z-0083-2012", "event_date_initiated": "2009-05-11", "event_date_posted": "2011-10-21", "recall_status": "Terminated", "event_date_terminated": "2011-10-25", "res_event_number": "52105", "product_code": "JQP", "k_numbers": [ "BK080052" ], "product_description": "Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09.\n\nIt is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.", "code_info": "S/W Versions 8.05, 8.06, 8.07, 8.08 and 8.09.", "firm_fei_number": "3001451449", "recalling_firm": "Data Innovations, Inc.", "address_1": "120 Kimball Ave Ste 100 120 Kimball Ave", "address_2": "Ste 100", "city": "South Burlington", "state": "VT", "postal_code": "05403-6837", "additional_info_contact": "Dave Potter\n802-264-3411", "reason_for_recall": "The \"previous result\" retrieved from the Specimen Management Database may not be the most recent \"previous result\".", "root_cause_description": "Software design", "action": "Data Innovations sent an \"IMPORTANT PRODUCT NOTICE\" dated May 11, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter offers temporary workarounds for customers to use until corrected versions of the software is complete. Versions of the corrections will be provided on a staggered schedule. Customers will be notified by e-mail. Questions regarding this notice are directed to Support at 802-658-1955.", "product_quantity": "188", "distribution_pattern": "USA (nationwide) and the country of Canada.", "openfda": { "k_number": [ "K833353", "K844907", "K802471", "K780881", "K800724", "K801167", "K761063", "K861779", "K893838", "K831830", "K810968", "K790543", "K830296", "K792129", "K983468", "K821531", "K113007", "K812604", "K801438", "K760739", "K800241", "K810631", "K770671", "K871339", "K823785", "K851321", "K782052", "K802251", "K822146", "K892060", "K953652", "K820427", "K801131", "K821058", "K801091", "K864557", "K934111", "K850659", "K790336", "K801210", "K822932", "K832746", "K822381", "K821807", "K861778", "K810063", "K881194", "K792158", "K801664", "K854265", "K834490", "K861844", "K823110", "K843365", "K871853", "K834300", "K802594", "K885292", "K822860", "K831574", "K831838", "K853026", "K770877", "K803312", "K822778", "K964460", "K781217", "K923316", "K820721", "K781173", "K861412", "K832760", "K800282", "K823679", "K840502", "K842401", "K781081", "K800242" ], "registration_number": [ "3020978007", "3008789114", "3015967359", "3031570369", "9616936", "3012104009", "9710492", "3015969360", "3003618481", "3010141591", "2029302", "3002807715", "2245451", "3010258456", "3008802064", "1220649", "3004145393", "3003453957", "1061932", "3003995437", "3002889627", "1225673", "3006543086", "8043723", "3042228064", "3011194542", "9615754", "3043012074", "3011806823", "3016764932", "1810909", "3006677029", "3009542936", "2243471", "9610126", "3027486032", "3021394862", "9615507", "3012436569", "8020888", "9616530", "3010097171", "2936921", "2431530", "3043012240", "3000126629", "3009404844", "3009731198", "3013896610", "3005798890", "3042989733", "3004959793", "9610865", "3003825930", "8030392", "3009711478", "3015426626", "3023268435", "8020030", "3038419886", "3007134734", "3015738702", "3002809144", "2531491", "3017086896", "3003559191", "3012118659", "3030413550", "9614673", "1058332", "3011393376", "3000148879", "3002710220", "2517506", "3005509212", "3037000637", "3011121740", "3003795116", "3003600763", "3002637618", "3010825766", "3006371704", "2432235", "1119779", "3015633428", "3006755541", "3004838836", "1950204", "3005862821", "9610816", "3013922172", "3013646951", "3035708936", "3024512705", "3030714692", "3009129531", "3011187792", "3025376092", "3010900203", "3008514395", "3040278125", "1000113657", "3016438761", "3002821232", "3015058854", "3004032053", "3009288740", "3013298431", "3003902721", "2954323", "8043909", "3027496319", "3015347724", "3005333358", "3004973408", "3014840402", "1219145" ], "fei_number": [ "3020978007", "3008789114", "3003516723", "3015967359", "3031570369", "3010700165", "3012104009", "3015969360", "3003618481", "3010141591", "3002807715", "2245451", "3001451449", "3010258456", "3008237827", "3008802064", "1220649", "3002803444", "3004145393", "3003453957", "3003116995", "3003559576", "3003995437", "3002889627", "3006461677", "3006543086", "3042228064", "1000306472", "3011194542", "3043012074", "3000203293", "3011806823", "3016764932", "1810909", "3006677029", "3009542936", "2243471", "3002829675", "3027486032", "3021394862", "3002806559", "3012436569", "1000307651", "3010097171", "2936921", "2431530", "3043012240", "3000126629", "3009404844", "3009731198", "3013896610", "3005798890", "3042989733", "3004959793", "3003825930", "3009711478", "3015426626", "3023268435", "3038419886", "3007134734", "3003500908", "3015738702", "3002809144", "3017086896", "3003559191", "3012118659", "3030413550", "3011393376", "3000148879", "3002710220", "2517506", "3005509212", "3037000637", "3003795116", "3003600763", "3002637618", "3010825766", "3006371704", "3007019572", "2432235", "1119779", "3015633428", "3002807167", "3006755541", "3004838836", "1950204", "3005862821", "3013922172", "3013646951", "3001573851", "3035708936", "3024512705", "3002671736", "3030714692", "3009129531", "3011187792", "3025376092", "3010900203", "3008514395", "3040278125", "1000113657", "3016438761", "3002821232", "3015058854", "3004032053", "3002806350", "3009288740", "3013298431", "3003902721", "3027496319", "3015347724", "3005333358", "3002808498", "3004973408", "3014840402", "1219145" ], "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }