Abbott Issues Correction for Faulty FreeStyle Libre 3 Sensors

Abbott has announced a medical device correction for select FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the U.S., after internal testing revealed that some units may deliver incorrect low glucose readings.

The company says this flaw, if unnoticed over time, could lead users to make unsafe treatment decisions, putting them at risk of severe health complications.

Abbott traced the issue to one specific production line used for both sensor models. The cause has now been fixed, and the company continues manufacturing to support ongoing orders and replacements without major supply concerns. About 3 million sensors in the U.S. fall under this action, though roughly half are believed to be expired or already used.

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Globally, Abbott has recorded 736 severe adverse events, including 57 in the U.S., along with seven deaths, none of which occurred in the United States. The company emphasizes that its FreeStyle Libre 3 readers and mobile apps are not affected, nor are other Libre systems such as FreeStyle Libre 14 day, Libre 2, Libre 2 Plus, or Libre Pro.

Consumers can verify whether their sensor is part of the correction at the official website, where Abbott is offering free replacements. Anyone currently wearing a confirmed affected sensor should stop using it immediately and dispose of it. Users are urged to rely on a blood glucose meter—or the meter built into the Libre 3 reader—if their sensor readings do not match how they feel.

Abbott is extending this correction to other countries where the sensors are distributed, underscoring the company’s role as a global healthcare leader committed to patient safety.