Millions of people with diabetes who depend on continuous glucose monitors (CGMs) are being urged to check their devices after the U.S. Food and Drug Administration (FDA) issued a safety alert warning that some Abbott glucose sensors may give inaccurate blood sugar readings—errors that could lead to dangerous treatment decisions.

The alert affects an estimated 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors worldwide. No other products in the FreeStyle Libre line are included.

According to the FDA, incorrect readings from these sensors have been connected to at least seven deaths and more than 700 serious injuries globally. Abbott reported that about 60 of those injuries occurred in the United States, though none resulted in fatalities.

 “Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor(s),” the FDA advised.

Inaccurate glucose readings can have grave consequences. When a sensor falsely reports low blood sugar, a person might eat more carbohydrates than necessary or reduce—or even skip—insulin doses. Over time, such missteps can destabilize diabetes management and lead to severe complications.

 “These decisions may pose serious health risks, including potential injury or death,” the FDA said, classifying the issue as a “potentially high-risk” safety problem. The agency noted that further updates will be provided as new information becomes available.

Abbott has attributed the faulty readings to a manufacturing issue, which the company says has now been resolved. It also stated that supply of replacement sensors and new orders should not be significantly impacted.

For millions of individuals relying on CGMs to make real-time, life-saving decisions, the alert underscores the importance of device accuracy—and the urgent need for swift action when problems arise.