12/03/2025
Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care
The FDA is aware that Abbott Diabetes Care has sent all affected customers a letter regarding an issue with certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors providing 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.
Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may provide incorrect low glucose readings