Millions of Abbott glucose sensors recalled after faulty readings linked to deaths

Millions of people rely on continuous glucose monitors to help manage diabetes. But a new alert from the U.S. Food and Drug Administration (FDA) warns that some sensors from Abbott may give incorrect blood sugar readings, which could lead to unsafe treatment decisions.

The issue affects about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, the FDA said. No other Libre products are included in the alert.

So far, the FDA has linked these incorrect readings to at least seven deaths and more than 700 serious injuries worldwide. About 60 of those injuries happened in the United States, according to Abbott. None of the U.S. cases were fatal.

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

Incorrect readings can be dangerous. If the device shows blood sugar levels that are falsely low, someone may eat more carbohydrates than needed or skip or reduce insulin, believing their blood sugar is under control.

Overtime, “these decisions may pose serious health risks, including potential injury or death, or other less serious complications,” the FDA alert stated.

The FDA said this issue is considered a “potentially high-risk” problem and updates will continue as more information becomes available.

Abbott said a manufacturing issue caused the problem, but the issue has now been fixed. The company expects no major supply delays for replacement devices or new orders.

Diabetes affects about 38 million people in the U.S., according to the U.S. Centers for Disease Control and Prevention.

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Abbott warns that some of its blood sugar monitors may need replacement due to incorrect readings