Overview
- Abbott and the FDA cite 736 serious adverse events worldwide and seven deaths potentially tied to incorrect low readings, with none of the deaths in the U.S.
- About three million Libre 3 and Libre 3 Plus sensors distributed in the U.S. are affected, roughly half of which are estimated to have already been used or expired.
- Users are advised to verify sensor serial numbers, discontinue impacted sensors immediately, and use a blood glucose meter or the reader’s built‑in meter when readings do not match symptoms.
- Libre 3 readers, mobile apps, and other Libre-branded sensors are not affected by the alert, according to Abbott and the FDA.
- The FDA characterized the situation as a potentially high‑risk issue rather than a formal U.S. recall, as regulators in multiple countries address the problem, including a recall reported in the UK.