Overview
- The FDA issued a high‑risk safety alert on Dec. 2 after Abbott determined some Libre 3 and Libre 3 Plus sensors can display falsely low glucose values.
- Abbott links the issue to a single production line, says the cause is fixed, and is providing free sensor replacements without charge.
- Users are instructed to stop using impacted sensors, check status at FreeStyleCheck.com, and rely on a meter if readings do not match symptoms.
- Abbott reports 736 severe adverse events worldwide, including 57 in the U.S., with all seven reported deaths occurring outside the U.S.
- In Canada, regulators recalled only Libre 3 Plus sensors and reported no related injuries or deaths in the country.