Abbott has received an FDA warning letter over accuracy concerns tied to its FreeStyle Libre continuous glucose monitors (CGMs). After an October 2025 inspection of Abbott’s Alameda, CA facility, the FDA said the company didn’t fully verify the performance of finished sensors before release, including testing after assembly, sterilization, and programming.

The FDA noted that Abbott relied too heavily on component-level testing, which didn’t guarantee accuracy once the sensor was fully built. Inspectors also flagged issues with how performance specs were shared with third-party manufacturers and how production sampling was handled. Abbott says it’s already taking corrective steps and working closely with the FDA and that the warning does not limit manufacturing or sales.

This letter follows Abbott’s November 2025 recall of roughly 3 million FreeStyle Libre 3 sensors, which were found to sometimes report falsely low glucose readings and related to seven deaths.

Abbott isn’t the only diabetes device company to draw FDA scrutiny recently. Dexcom received its own FDA warning last year and Beta Bionics, the maker of the iLet insulin pump, just received an FDA warning letter, raising concern in the diabetes community about device reliability and transparency.

Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a physician before making changes to your healthcare.