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Abbott issues US device correction for some glucose monitors over faulty readings risk
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Abbott issues US device correction for some glucose monitors over faulty readings risk
Nov 24, 2025 8:39 AM

Nov 24 (Reuters) -

Abbott Laboratories ( ABT ) said on Monday it has begun a

correction in the United States for certain FreeStyle Libre 3

and FreeStyle Libre 3 Plus glucose monitoring sensors after

internal testing showed some units may report falsely low

glucose readings.

About 3 million sensors are affected in the U.S.,

roughly half of which are estimated to have expired or already

been used, the company said.

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.

The problem, tied to one production line, could lead to

incorrect treatment decisions for people with diabetes,

including excessive carbohydrate intake or missed insulin doses,

posing serious health risks, the company said.

A correction is an action to address a problem with a

product already on the market or in use without physically

removing it from circulation.

Last year, Abbott issued a

similar correction

for a small number of FreeStyle Libre 3 sensors in the

United States that could report inaccurately high glucose

readings.

Abbott said it has resolved the manufacturing issue and

continues to produce sensors to meet replacement and new orders

without significant supply disruptions.

Users can check if their sensors are affected and

request free replacements at www.freestylecheck.com.

The company 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.

Other Libre products, readers and apps are not affected,

and the correction is also being implemented in other countries

where Libre 3 and Libre 3 Plus sensors are sold, Abbott said.

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