Abbott Diabetes Care has alerted patients that the FreeStyle Libre 3 and Libre 3 Plus glucose sensors may provide incorrect low glucose readings. 

The FDA posted an Early Alert about the issue on December 2, 2025, following Abbott’s November 24, 2025 letter to affected patients and providers. 

“If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications,” the FDA notice said. 

As of November 14, 2025, Abbott has reported 736 serious injuries and seven deaths potentially related to the issue. Of those, 57 injuries and none of the deaths were in the US. 

Abbott said the issue was found to be related to a single production line and involved about 3 million Libre 3 and Libre 3 Plus sensors in the US from that line, about half of which are estimated to have expired or been used. According to the company, the issue has now been resolved. 

Abbott continues to produce the two types of sensors and to fulfill replacement and new orders and does not anticipate significant supply disruptions. 

The issue does not affect FreeStyle Libre 3 readers and mobile apps or other Libre products, including FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, Libre Pro sensors, or Abbott biowearables.

The FDA advised healthcare clinicians the following: 

• Inform your patients of the issue and instruct them to visit www.FreeStyleCheck.com to confirm whether their sensors are affected. Abbott Diabetes Care has provided a patient letter to use with your patients.
• If your patient is currently wearing or has a FreeStyle Libre 3 or Libre 3 Plus sensor that has been confirmed as potentially affected on that link or by a customer service representative, have them immediately discontinue use and dispose of the affected sensor(s).
• Patients can request a replacement for any potentially affected sensor(s) on www.FreeStyleCheck.com, by selecting “CONFIRM SENSOR SERIAL NUMBER” and entering a valid serial number. If their sensor is potentially affected, they will be instructed to enter their contact information so a replacement product can be sent to them at no cost.
• Patients can use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 Reader to make treatment decisions when sensor readings don’t match symptoms or expectations.
• Sales representatives will contact clinicians with instructions to dispose of impacted samples. Sample replacements will be sent.

Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker and BlueSky @miriametucker.bsky.social