FDA Issues Alert for Abbott FreeStyle Glucose Monitor Sensors Due to Potential for Incorrect Readings

The U.S. Food and Drug Administration (FDA) has issued an alert concerning specific FreeStyle glucose monitor sensors from Abbott Diabetes Care, warning of a potential for incorrect low glucose readings. The agency is advising individuals using these devices to verify if their sensors are affected and to discontinue use immediately if they are. Abbott Diabetes Care has initiated a voluntary removal from use and sale of the impacted sensors and is providing a dedicated website for users to check their devices and request replacements.

The alert specifically impacts FreeStyle Libre 3 Sensor (Model Numbers: 72081-01, 72080-01) and FreeStyle Libre 3 Plus Sensor (Model Numbers: 78768-01, 78769-01). The FDA noted that neither the FreeStyle Libre 3 readers nor the mobile applications are affected by this issue. Furthermore, other Libre product lines, including FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, and Libre Pro sensors, as well as other Abbott biowearables, remain unaffected.

Abbott Diabetes Care has alerted distributors, healthcare providers, and customers to the issue. Patients are instructed to visit http://www.freestylecheck.com to confirm if their specific sensor serial number is impacted. The serial number can be found within the FreeStyle Libre 3 app or reader, on the sensor applicator label, or on the sensor carton. For those using a sensor connected to an insulin delivery device, the user manual for that device should be consulted to locate the serial number. If a sensor is confirmed to be potentially affected, users are directed to immediately stop using it and dispose of it. A replacement for any potentially affected sensor can be requested at no cost through the same website. Abbott advises individuals to rely on a blood glucose meter or the built-in meter on their FreeStyle Libre 3 Reader for treatment decisions if their sensor readings do not align with their symptoms or expectations.

Healthcare providers are being urged to inform their patients about this early alert and guide them to the http://www.freestylecheck.com website for verification. They are also advised to instruct patients to discontinue use and dispose of affected sensors and to use alternative blood glucose monitoring methods when necessary. Sales representatives are expected to contact healthcare providers with instructions for handling and disposing of impacted samples, with replacements to be provided. Distributors and wholesalers are directed to inform their customers about this urgent medical device correction and to return affected sensors through their normal return processes. They are also tasked with checking their inventory for sensors from the identified affected lots, removing them, and returning them.

Abbott Diabetes Care has indicated that the reason for this alert is that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may provide inaccurate low glucose readings. If these incorrect readings go undetected, they could lead to inappropriate treatment decisions for individuals managing diabetes. Such decisions, including excessive carbohydrate intake or delayed or skipped insulin doses, could pose significant health risks, potentially leading to serious injury or even death, or other less severe complications. As of November 14, 2025, Abbott has reported 736 serious injuries and seven deaths associated with this issue.

The FreeStyle Libre 3 and FreeStyle Libre 3 Plus Continuous Glucose Monitoring Systems are designed for individuals aged four and older with diabetes and are intended to replace blood glucose testing for treatment decisions. These systems are capable of detecting trends, tracking patterns, and identifying episodes of hyperglycemia and hypoglycemia, aiding in therapy adjustments. The systems are also designed to communicate with digitally connected devices, and users can manually control actions for therapy decisions.

Individuals in the U.S. experiencing adverse reactions, quality problems, or who have questions regarding this recall can contact Abbott Diabetes Care at 1-833-815-4273 or visit the support contact page on http://www.freestyle.abbott/us-en/support/contact-us.html. The FDA is continuing to review this issue and will provide updates as more significant information becomes available.

Article by Mel Anara, based upon information from the U.S. Food and Drug Administration.

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