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The Food and Drug Administration (FDA) issued a stark warning about disruptions on Tuesday Blood glucose meters which may have contributed to seven deaths and hundreds of serious injuries.
Medical device manufacturer Abbott also warned users and healthcare distributors last Monday, urging them to immediately stop using or discard all FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor devices.
The FDA described the problem as a “potentially high-risk” problem.
“As of November 14, 2025, Abbott has reported 736 serious injuries and seven deaths related to this issue,” the FDA said. Abbott noted that 57 of the “serious adverse events” occurred in the U.S., and none of the deaths occurred in the country.
DIABETES RESEARCH REVEALS DIAGNOSIS GAP EFFECTING MILLIONS OF PEOPLE
A diabetic teenager fitted with a glucose sensor. (BSIP/Universal Images Group/Getty Images)
Both the FDA and Abbott warned that the monitors “may give false low glucose readings” and advised patients to check if their sensors are affected.
“If improperly low glucose readings go undetected for an extended period of time, they can lead to incorrect treatment decisions for people with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses,” the FDA and Abbott said. “These decisions can pose serious health risks, including possible injury or death, as well as other less serious complications.”
OZEMPIC AND SIMILAR DRUGS MAY DISRUPT THE COMMON MEDICAL PROCEDURE, RESEARCH WARNS
A four-year-old child shows a blood glucose sensor on his arm that measures his blood glucose in Berlin, Germany, on August 3, 2021. (Jörg Carstensen/Photo Alliance / Getty Images)
The sensors involved are real-time monitoring devices with alarm capabilities, designed to help manage diabetes in individuals aged 4 years and older.
Abbott said the company has identified and resolved the problem production problem regarding these devices, noting that the problem affects only one of the many production lines used to make the sensors. About 3 million sensors from the affected line are affected, the company said.
The manufacturer said it will produce new devices to meet replacement and new orders and that the company does not expect any significant supply disruptions.
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| ABBOT | ABBOTT LABORATORIES | 126.32 | -1.72 |
-1.34% |
Consumers can drop by www.FreeStyleCheck.com to determine if their sensors are affected and to obtain a replacement at no charge, Abbott added.
Abbott Laboratories signage seen at the campus headquarters in Abbott Park, Illinois, on Friday, May 21, 2010. (Tim Boyle/Bloomberg/Getty Images)
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The company emphasized that there are no other sensors, readers or apps from the Libre family.
