Abbott Laboratories has initiated a voluntary correction for certain FreeStyle Libre 3 and Libre 3 Plus continuous glucose monitoring (CGM) sensors after internal analyses showed that a limited number of units may falsely report low glucose levels.
The issue has been traced to a specific manufacturing line. In the U.S., the problem affects roughly 3 million sensors, although Abbott says about half of these may already have been used or have expired.
Abbott says it has already fixed the manufacturing issue and is offering free replacement sensors to users with affected units.
According to Abbott, other Libre products—including the reader, the app, and other sensor models—are not impacted.
The company reported 736 severe adverse event reports globally, including seven deaths potentially linked to the issue.
The U.S. Food and Drug Administration (FDA) classifies this as a “device correction,” meaning the affected sensors are not being physically removed from the market.
