Abbott Diabetes Care has warned that some of its FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose sensors may produce incorrect low glucose readings. Internal testing traced the issue to a single production line. About 3 million sensors were affected; Abbott estimates roughly 1.5 million of those have expired or been used.
The company said customers who confirm their device is affected should immediately discontinue use and dispose of it. Abbott warned that undetected incorrect low readings over time can lead to wrong treatment decisions—such as excessive carbohydrate intake or skipping or delaying insulin—that may pose serious health risks, including potential injury or death.
Abbott reported seven deaths linked to the issue; all occurred outside the United States. The company also reported 736 “severe” injuries, 57 of which occurred within the U.S. Abbott said it continues to produce sensors using the same process and does not expect significant supply disruptions.
Customers can check whether their sensor is affected at FreeStyleCheck.com and Abbott will replace faulty sensors at no charge. The U.S. Food and Drug Administration has posted more information on the recall.