Abbott issues correction for Freestyle Libre 3 and 3 Plus sensors

ABBOTT PARK, Ill. — Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing determined that some sensors may provide incorrect low glucose readings.  

This action involves approximately 3 million Libre 3 and Libre 3 Plus sensors in the U.S. from one production line, about half of which are estimated to have expired or been used. Globally, Abbott has received reports of 736 severe adverse events (57 in the U.S.) and seven deaths (none in the U.S.) potentially associated with 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.  

Important instructions for users: 

• Consumers should visit www.FreeStyleCheck.com to confirm whether their sensor is potentially affected by this medical device correction. Abbott will replace any potentially affected sensors at no charge. Detailed instructions on how to check sensors and request a replacement are available on the website. 
• If consumers are currently wearing or have a sensor that has been confirmed as potentially impacted on www.FreeStyleCheck.com or by a customer service representative, they should immediately discontinue use and dispose of it.  
• Consumers should use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader to make treatment decisions when sensor readings don’t match symptoms or expectations. 

FreeStyle Libre 3 readers and mobile apps are not impacted. Additionally, no other Libre products (FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or FreeStyle Libre Pro sensors) or Abbott biowearables are impacted.