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Abbott Diabetes Care, Inc.

57 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 se recall (Z-1020-2026)Abbott Diabetes Care, Inc.2026-01-14
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre recall (Z-1021-2026)Abbott Diabetes Care, Inc.2026-01-14
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre recall (Z-1022-2026)Abbott Diabetes Care, Inc.2026-01-14
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre recall (Z-1023-2026)Abbott Diabetes Care, Inc.2026-01-14
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Gl recall (Z-2692-2024)Abbott Diabetes Care, Inc.2024-08-27
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Andr recall (Z-0734-2024)Abbott Diabetes Care, Inc.2024-01-16
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System recall (Z-2414-2023)Abbott Diabetes Care, Inc.2023-08-17
FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Lib recall (Z-1273-2023)Abbott Diabetes Care, Inc.2023-04-06
FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Lib recall (Z-1274-2023)Abbott Diabetes Care, Inc.2023-04-06
FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Lib recall (Z-1275-2023)Abbott Diabetes Care, Inc.2023-04-06
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 000938159881 recall (Z-1556-2020)Abbott Diabetes Care, Inc.2020-02-28
Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 recall (Z-1557-2020)Abbott Diabetes Care, Inc.2020-02-28
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810 recall (Z-1558-2020)Abbott Diabetes Care, Inc.2020-02-28
FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room t recall (Z-1211-2014)Abbott Diabetes Care, Inc.2014-03-18
FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSe recall (Z-1212-2014)Abbott Diabetes Care, Inc.2014-03-18
FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 recall (Z-0485-2014)Abbott Diabetes Care, Inc.2013-12-17
FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 c recall (Z-0486-2014)Abbott Diabetes Care, Inc.2013-12-17
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use recall (Z-1245-2013)Abbott Diabetes Care, Inc.2013-05-09
FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Mon recall (Z-1258-2011)Abbott Diabetes Care, Inc.2011-02-15
Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips recall (Z-0994-2011)Abbott Diabetes Care, Inc.2011-02-09
Abbott Diabetes Care Optium EZ Blood Glucose Test Strips; recall (Z-0995-2011)Abbott Diabetes Care, Inc.2011-02-09
Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips; MediSense Optium Blood G recall (Z-0996-2011)Abbott Diabetes Care, Inc.2011-02-09
Abbott Diabetes Care, Optium Blood Glucose Test Strips; recall (Z-0997-2011)Abbott Diabetes Care, Inc.2011-02-09
Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips; recall (Z-0998-2011)Abbott Diabetes Care, Inc.2011-02-09
Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips; Precision Xtra Blood Gluco recall (Z-0999-2011)Abbott Diabetes Care, Inc.2011-02-09
Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test ; recall (Z-1000-2011)Abbott Diabetes Care, Inc.2011-02-09
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB SYSTEM KIT(ORA recall (Z-0820-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, SYSTEM KIT PACKAGI recall (Z-0821-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, SYSTEM KIT PACKAGI recall (Z-1444-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB Warranty Kit X recall (Z-1445-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Replacement Kit, T recall (Z-1446-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Reorder/Warranty K recall (Z-1447-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB System Kit MG, recall (Z-1448-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Busines recall (Z-1449-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Busines recall (Z-1450-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ABB NAV Dutch System Kit CE RE, AND recall (Z-1451-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business 1 recall (Z-1452-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business 1 recall (Z-1453-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL (E recall (Z-1454-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL EM recall (Z-1455-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MG EMEA recall (Z-1456-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, System Kit, Business 1, (Orange). A recall (Z-1457-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abb recall (Z-1458-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, ABB Transmitter Navigator. Abbott I recall (Z-1459-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, Assy, Transmitter Poly Contac, Abbo recall (Z-1460-2010)Abbott Diabetes Care, Inc.2010-04-30
Freestyle Navigator Continuous Glucose Monitor System, Clinical Transmitter, Abbott Item N recall (Z-1461-2010)Abbott Diabetes Care, Inc.2010-04-30
FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with recall (Z-1936-2009)Abbott Diabetes Care, Inc.2009-09-01
Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, recall (Z-1196-2009)Abbott Diabetes Care, Inc.2009-05-20
Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood recall (Z-1813-2008)Abbott Diabetes Care, Inc.2008-09-11
Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and recall (Z-0112-2008)Abbott Diabetes Care, Inc.2008-02-14
Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit. recall (Z-0856-2007)Abbott Diabetes Care, Inc.2007-06-07
Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), recall (Z-0709-2007)Abbott Diabetes Care, Inc.2007-05-23
Abbott brand FreeStyle Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harb recall (Z-1306-06)Abbott Diabetes Care, Inc.2006-08-03
Abbott brand FreeStyle Flash Blood Glucose Meter, distributed by Abbott Diabetes Care, 142 recall (Z-1307-06)Abbott Diabetes Care, Inc.2006-08-03
FreeStyle Connect Point of Care Blood Glucose Monitoring System, including Control Solutio recall (Z-0604-06)Abbott Diabetes Care, Inc.2006-03-15
FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes recall (Z-0605-06)Abbott Diabetes Care, Inc.2006-03-15
FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Managemen recall (Z-1594-05)Abbott Diabetes Care, Inc.2005-10-01

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Every clearance here is in the API, with alerts when new ones post.