Abbott Diabetes Care has warned that some FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose sensors can produce incorrect low glucose readings. Internal testing traced the problem to a single production line. About 3 million sensors are affected, and Abbott estimates roughly 1.5 million of those have already been used or expired.
Abbott advises customers who confirm their sensor is on the affected list to stop using it immediately and dispose of it. The company warned that undetected false low readings can prompt incorrect treatment choices—such as consuming too many carbohydrates or skipping or delaying insulin—which can lead to serious health consequences, including injury or death.
Abbott reported seven deaths linked to the issue; all occurred outside the United States. The company also reported 736 severe injuries worldwide, 57 of which were reported in the U.S. Abbott said it continues to manufacture sensors using the same process and does not expect major supply disruptions.
Customers can check whether a sensor is affected at FreeStyleCheck.com. Abbott will replace faulty sensors at no charge. The U.S. Food and Drug Administration has posted additional information on the recall.