Abbott Initiates Medical Device Correction for Freestyle Libre 3 Sensors in the U.S. After Reports of Severe Adverse Events and Deaths

Abbott Laboratories has initiated a medical device correction in the United States for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring (CGM) sensors following internal testing that revealed some sensors may provide incorrectly low glucose readings. This issue primarily affects sensors manufactured on one specific production line, with approximately 3 million sensors impacted in the U.S., about half of which are estimated to be expired or already used.

The incorrect low glucose readings can lead to serious health risks. If undetected over an extended period, these false readings could cause people with diabetes to make incorrect treatment decisions, such as consuming excessive carbohydrates or delaying/skipping insulin doses. Such decisions increase the risk of severe complications, including potential injury or death. Globally, Abbott has reported 736 severe adverse events related to the issue, including 57 in the U.S., and seven deaths outside the U.S. No deaths have been reported in the U.S. linked to this problem.

Abbott has taken steps to identify and resolve the manufacturing issue. The company advises affected users to visit www.FreeStyleCheck.com to determine if their sensor is part of the medical device correction. Any affected sensors will be replaced free of charge, and users are urged to discontinue use of potentially impacted sensors immediately. Abbott recommends that users verify sensor readings against a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader, especially when sensor readings do not match symptoms or expectations. The issue only affects certain Libre 3 sensors and does not affect Libre 3 readers, mobile apps, or other Abbott Libre products.

Abbott continues to produce Libre 3 and Libre 3 Plus sensors to meet replacement and new order demands and does not anticipate significant supply disruptions. The company emphasizes the importance of proper sensor use and ongoing monitoring to ensure safe diabetes management during this corrective phase.

References

Abbott initiates medical device correction for certain FreeStyle Libre® 3 and FreeStyle Libre 3 Plus sensors in the U.S., Abbott, 24 November 2025, https://abbott.mediaroom.com/press-releases?item=124718