{ "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": "167216", "product_res_number": "Z-0203-2019", "event_date_initiated": "2018-08-29", "event_date_created": "2018-10-22", "recall_status": "Terminated", "event_date_terminated": "2019-02-05", "res_event_number": "81005", "product_code": "JQP", "product_description": "IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).", "code_info": "accessory driver version number 8.00.0001", "firm_fei_number": "3001451449", "recalling_firm": "Data Innovations, LLC", "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": "Customer service\n802-658-1955", "reason_for_recall": "Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) instrument.\nThis has been determined to be a driver malfunction. When an instrument transmits results from a quality control (QC) sample ID\n(\"Q^Control\" in SPM segment), and the option Hold Results Until Complete is enabled, the results do not parse into IM. The\ncommunication Trace shows the sample being transmitted, but no information is logged in the Specimen Event Log (SEL).\nThere is a potential for harm if QC results are not processed, downstream auto verification rules may misfire based on missing QC\nresults leading to a delay in, or incorrect treatment. QC results will not be available for evaluation by the lab.\nThere have been no reported instances of patient harm from this malfunction.", "root_cause_description": "Software design", "action": "On August 29, 2018, the firm began notifying affected customers via an Important Medical Device Recall/Field Safety Notice Information letter. The communication advised customers of the issue with Abbott Diagnostics Alinity ci-series (abdicqii) instrument not processing QC results if \"Hold Results Until Complete\" is enabled.\n\nCustomers are advised to do the following:\n\n1. Apply the updated v8.00.0002 version of Instrument Manager driver to correct this issue. The updated version is available around September 7, 2018.\n\n2. Use the following workaround: Disable the \"Hold Results Until Complete\" option in Instrument Manager (driver configuration). If Hold Results Until Complete logic is required, there is no workaround; discontinue use until updated driver is installed.\n\n3. Distribute notification on to anyone in your organization who needs to be aware.\n\n4. Complete the customer response form and return to recalling firm.\n\nIf you have any questions regarding this recall, please contact Support Email USA: northamerica-support@datainnovations.com, or Support Phone: +1(802) 658-1955.", "product_quantity": "9", "distribution_pattern": "Distributed to OK. Foreign distribution to Argentina, Hong Kong, Malaysia, Thailand, Germany, Jordan, Australia, and Switzerland.", "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" } } ] }