Overview
- The recall covers certain FreeStyle Libre 3 Plus sensors that can falsely signal low glucose levels, prompting risky treatment decisions such as extra carbohydrate intake or delayed insulin.
- The FDA issued an early safety alert urging users to stop using specific Libre 3 and Libre 3 Plus sensors that generate incorrect low readings.
- Abbott reports about 736 severe adverse events and seven deaths worldwide potentially linked to the issue, and the company declined to disclose the countries where they occurred.
- Abbott traced the problem to one production line, says it has been resolved, and estimates about 3 million affected sensors were distributed in the U.S., roughly half already used or expired.
- Users are directed to verify serial numbers at www.FreeStyleCheck.com, discard affected sensors for free replacements, and confirm with a blood glucose meter when readings do not match symptoms.