December 4, 2025
Abbott’s FreeStyle Libre is a device that measures glucose levels via a sensor applied to the upper back of the arm.
The Food and Drug Administration (FDA) issued a warning about malfunctioning blood glucose monitoring devices that have been linked to seven deaths and more than 700 serious injuries worldwide. The alert issued on Dec 2 notes that Abbott Diabetes Care glucose monitors worldwide provided users with incorrect 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,” the agency said. “These decisions may pose serious health risks, including potential injury or death, or other less serious complications.” The FDA notes in its alert.
The FDA considers this a “potentially high-risk issue” and says it will continue to update its website as more information emerges.
Abbott also issued a warning stating that 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors are affected. Libre3 readers and mobile apps are not impacted. No other Libre (FreeStyle Libre 14-day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or Libre Pro) or Abbott biowearables are affected by this issue.
“Abbott has identified and resolved the cause of the issue, which relates to one production line among several that make Libre 3 and Libre 3 Plus sensors. The company continues to produce Libre 3 and Libre 3 Plus sensors to fulfill replacement and new orders and does not expect significant supply disruption,” the company stated in a press release.
Abbott advises its customers to check whether their sensors are affected and to stop using the device and dispose of it immediately. The company also noted that among the 60 injuries reported in the U.S., none were fatal.
Patients can visit FreeStyleCheck.com to see if their sensors are affected and receive a replacement at no cost.
According to the Centers for Disease Control and Prevention, about 38 million people in the U.S. are living with diabetes. The disease is the seventh leading cause of death in the United States.
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