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The U.S. Food and Drug Administration (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.
This communication is an FDA Early Alert. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abbott Diabetes Care at 1-833-815-4273 or https://www.freestyle.abbott/us-en/support/contact-us.html.
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