Overview
- The action covers Libre 3 sensors with model numbers 72081-01 and 72080-01 (UDI-DI 00357599818005, 00357599819002) and Libre 3 Plus sensors 78768-01 and 78769-01 (UDI-DI 00357599844011, 00357599843014).
- The FDA says certain sensors can display incorrect low-glucose values, creating a risk of inappropriate treatment for people with diabetes.
- Users can confirm serial numbers at FreeStyleCheck.com; affected sensors in use should be removed and disposed of, with free replacements available.
- The recall does not include FreeStyle Libre 3 readers, mobile apps, other Libre sensors, or Abbott biowearable devices.
- Abbott has reported 860 serious injuries and seven deaths as of January 7, with no additional deaths since November 14 and none in the United States, and clinicians and distributors have been directed to notify patients and retrieve recalled inventory.