The US Food and Drug Administration has issued an alert after identifying seven deaths and more than 700 serious injuries worldwide linked to incorrect glucose readings from certain Abbott FreeStyle Libre 3 and Libre 3 Plus sensors.

The agency describes this as a “potentially high-risk issue” and has published detailed information on the affected products, stressing that it will continue updating its guidance as new information becomes available.

Incorrect glucose readings can lead to inappropriate treatment decisions — for example, taking in too many carbohydrates or delaying insulin. Over time, these decisions can pose serious health risks.

Abbott says the problem stems from one production line and affects around 3 million sensors in the US, about half of which are estimated to have already expired or been used. The company reports 736 severe adverse events globally, including the seven deaths, though none of the fatal cases occurred in the US. The manufacturing issue has been resolved, and Abbott does not expect significant supply disruptions.

What users should do:

The FDA urges all patients using these sensors to check immediately whether their device is affected. Sensors confirmed as impacted should be discontinued and safely disposed of. Abbott will replace affected sensors free of charge.

Users can verify their sensor at FreeStyleCheck.com, where step-by-step instructions are available. When readings do not match symptoms, patients should confirm their glucose levels with a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader.

Abbott’s correction does not affect FreeStyle Libre 14 day, Libre 2, Libre 2 Plus, or Libre Pro sensors, nor the Libre 3 readers or mobile apps. The action is being implemented in all countries where Libre 3 and Libre 3 Plus sensors are distributed.

For support, consumers can visit FreeStyleCheck.com, call 1-833-815-4273 (8 a.m.–8 p.m. ET, seven days a week), or use Abbott’s live chat service, available 24/7.