FDA issues early alert on Abbott glucose monitor sensors

The Food and Drug Administration has cautioned people to stop using FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitor sensors after manufacturer Abbott (ABT) Diabetes Care reported the products may be linked to at least seven deaths. The agency said, “The FDA is aware that Abbott Diabetes Care has issued a letter to distributors, health care providers, and affected customers recommending certain glucose monitor sensors be removed from where they are used or sold…Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor…Abbott Diabetes Care stated that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. 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. As of November 14, 2025, Abbott has reported 736 serious injuries, and seven deaths associated with this issue.”