FDA alerts on defective Abbott Libre 3 glucose monitors causing false readings

The FDA has issued an early alert about a defect in Abbott Libre 3 glucose monitors that can produce false low readings, leading to serious health risks including injuries and fatalities. Affected devices should no longer be used, and patients are advised to consult resources provided by the FDA for next steps.
Dec. 5, 2025

The U.S. Food and Drug Administration (FDA) has published an “Early Alert” regarding a defect in certain Abbott Diabetes Care glucose monitors causing patients to receive false low glucose readings. Abbott has already alerted affected customers, according to the FDA.

The following sensors should no longer be used:

  • FreeStyle Libre 3 Sensor
    • Model Numbers: 72081-01, 72080-01
    • Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002
  • FreeStyle Libre 3 Plus Sensor
    • Model Numbers: 78768-01, 78769-01
    • Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014

The FDA has a full list of impacted products on their website. They also list resources and next steps for affected patients. So far, more than 700 people have been seriously injured and seven people have died due to this issue.

About the Author

Erin Brady

Managing Editor

Erin Brady is Managing Editor of Medical Laboratory Observer.

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