Abbott has initiated a medical device correction in the United States for specific batches of its FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose sensors after internal testing found that some units may deliver inaccurate low glucose readings. Such incorrect readings, if not identified over time, could lead people with diabetes to make inappropriate treatment decisions—such as consuming excess carbohydrates or delaying insulin doses—which may pose serious health risks, including potential injury or death.

The issue was traced to one production line among several manufacturing Libre 3 sensors. Abbott stated that the root cause has been identified and resolved, and production continues for both replacement and new orders without anticipated supply disruptions. The action covers around 3 million sensors in the USA, with an estimated half already used or expired. Globally, Abbott has received 736 reports of severe adverse events and seven deaths potentially linked to the issue, though none of the deaths occurred in the USA.

Users with confirmed impacted sensors are advised to stop using them immediately and switch to a blood glucose meter for treatment decisions. The correction does not affect Libre 3 readers, apps, other Libre system products, or Abbott’s other biowearables. Abbott is also implementing this correction in other countries where the sensors are distributed.