Abbott Corrects 3 Million Glucose Sensors for Faulty Low Readings
Abbott initiated a medical device correction for approximately 3 million FreeStyle Libre 3 and 3 Plus glucose sensors in the U.S. after internal testing revealed some units may report falsely low glucose readings. The company has received 736 reports of severe adverse events and seven deaths globally that may be linked to the faulty readings, which could lead to incorrect treatment decisions in diabetes patients.
What happened
Abbott Laboratories initiated a medical device correction on 24 November 2025 for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitoring sensors after internal testing found that some units may report falsely low glucose readings. About 3 million sensors were affected in the U.S., with roughly half estimated to have expired or already been used.
The problem was traced to one production line and could lead to incorrect treatment decisions for people with diabetes, including excessive carbohydrate intake or missed insulin doses. Abbott has received 736 reports globally of severe adverse events and seven deaths that may be linked to the issue, none of which occurred in the United States.
Reported impact
Incorrect low glucose readings may lead patients with diabetes to make wrong treatment decisions regarding insulin administration or dietary choices. Seven deaths worldwide have been linked to the issue, with 57 adverse events reported in the U.S.
Index analysis
The failure to accurately report glucose levels, particularly falsely low readings, poses serious health risks to diabetes patients who rely on the sensors for treatment decisions. Patients may increase carbohydrate intake or reduce insulin doses based on inaccurate sensor data, creating dangerous health consequences.
Governance controls
Abbott advised users to stop using any confirmed affected sensors immediately and to rely on a blood glucose meter for treatment decisions when sensor readings do not match symptoms. The company provided a website (www.freestylecheck.com) for users to check if their sensors were affected and request free replacements.
Abbott stated it had resolved the manufacturing issue and continued to produce sensors to meet replacement and new orders. The correction was also being implemented in other countries where Libre 3 and Libre 3 Plus sensors were sold.
Classification
Sources and evidence
This record was researched and written by the Index, based on the following original reporting.