Overview
- The FDA issued an early alert on Dec. 2 after Abbott initiated a medical device correction for select FreeStyle Libre 3 and Libre 3 Plus sensors that can report falsely low glucose levels.
- Health Canada recalled certain Libre 3 Plus sensors, and the UK is among roughly 17 countries where regulators have issued warnings or recalls.
- Abbott has reported 736 serious adverse events and seven deaths potentially linked to the problem, with the fatalities reported outside the United States.
- Approximately 3 million sensors in the U.S. from the implicated production line are covered by the action, and Abbott estimates about half have already been used or expired.
- Users are advised to check affected model numbers and UDIs at FreeStyleCheck.com, stop using confirmed affected sensors for treatment decisions, and use a blood glucose meter if readings do not match symptoms.