Abbott has initiated a medical device correction for sensors used in certain FreeStyle Libre 3 continuous glucose monitoring (CGM) systems in the US after determining that a number of them may be providing incorrect low glucose readings.
Abbott said the correction affects around three million sensors used in the company’s FreeStyle Libre 3 and FreeStyle Libre 3 Plus CGMs. Around half of the total are estimated to have expired or been used.
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The company revealed that it has received 736 severe adverse event reports globally relating to the issue, including 57 in the US. Seven deaths, none of which occurred in the US, are also “potentially” associated with the issue, according to the American medtech giant.
Abbott added that neither its FreeStyle Libre 3 readers and mobile apps, other Libre products, or any of its biowearables are impacted by the correction.
While the business has not disclosed the specific nature of the sensor fault, it says that it has now been rectified and traced to one of its three production lines that produce the sensors. The company added that it is continuing to produce Libre 3 and Libre 3 Plus sensors to fulfil replacement and new orders and does not expect any significant supply disruptions.
Consumers are now advised to visit www.FreeStyleCheck.com to confirm whether their sensor is potentially affected by the correction, with Abbott vowing to replace any potentially affected sensors free of charge.
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By GlobalDataOver time, incorrect low glucose readings may lead to incorrect treatment decisions for individuals living with diabetes such as excessive carbohydrate intake or skipping or delaying insulin doses.
While the US Food and Drug Administration (FDA) has not classified Abbott’s correction as yet, this is not the first time problems with the company’s Freestyle Libre 3 sensors have come to light.
In September 2024, the FDA classified Abbott’s July 2024 recall for a ‘limited number’ of FreeStyle Libre 3 sensors in the US as Class 1, the agency’s most serious recall designation, due to the possibility that some of them may provide incorrect high glucose readings.
A GlobalData market model reveals that Abbott is the leader in the CGM and insulin pump space in the US in 2025, holding a market share of 22.5%, ahead of Dexcom and Insulet in second and third place, with market shares of 16.2% and 14.5%, respectively.
According to GlobalData analysis, the global CGM market is growing at a CAGR of 8.4% and is forecast to reach a valuation of around $14.1bn by 2034, up from $6.3bn in 2024.
