By VETTAPHARMA reporter: The U.S. Food and Drug Administration (FDA) has published a safety alert indicating that Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring (CGM) sensors after internal testing found that some units may provide incorrect low glucose readings. (FDA.gov, Jan. 15 2026).
According to the FDA’s announcement, the action was initiated by Abbott in response to manufacturing issues identified on one production line that resulted in certain sensors reporting inaccurately low glucose measurements. The affected devices are FreeStyle Libre 3 and Libre 3 Plus glucose monitoring sensors, which are used by millions of people living with diabetes to continuously monitor blood glucose levels.
Those inaccurate low readings, if undetected, can lead users to make incorrect treatment decisions, such as increasing carbohydrate intake or modifying insulin dosing inappropriately, potentially resulting in serious health consequences. The FDA alert follows reports of 736 severe adverse events globally, including seven deaths linked to the issue — although none of those deaths occurred in the United States.
The medical device correction affects approximately three million sensors distributed in the U.S., with about half estimated to have expired or already been used, according to reporting on the development. Abbott has identified and resolved the root cause of the issue and continues to produce and distribute replacement sensors without expected supply disruptions.
The FDA and Abbott are urging anyone using a potentially impacted sensor to visit https://www.freestylecheck.com/int-en/home.html to verify their device’s serial number and confirm whether it falls within the subset requiring replacement. Consumers with affected sensors should stop using them immediately and rely on alternative glucose monitoring methods — such as a fingerstick glucose meter or built-in reader — when readings do not match symptoms or expectations. Affected sensors will be replaced at no cost.
According to the FDA notice, no other FreeStyle Libre products — including other generations of sensors, the Libre 3 reader, or associated mobile applications — are impacted by this correction. The action is characterized as a medical device correction, which means affected units remain in use while replacements are provided, rather than an immediate market wide removal.
In addition to the most recent correction, Abbott previously issued a voluntary device correction in 2024 for a small number of FreeStyle Libre 3 sensors that could provide inaccurate high readings, illustrating ongoing quality control efforts for these widely used devices.
Healthcare providers, pharmacies, and individuals dependent on continuous glucose monitoring are encouraged to review the FDA safety alert, verify their device status, and take appropriate action to ensure accurate glucose tracking — a critical component of effective diabetes management.
Source Credits
1. FreeStyleCheck. (2025). Home. Abbott. Click here
2. U.S. Food and Drug Administration. (2026, January 15). Abbott initiates medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the U.S. Click here
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