By Ciara Perez, Senior Multimedia Correspondent
iSkyNews.com (ISC News) – Published January 21st, 2026
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Abbott Issues Medical Device Correction for Certain FreeStyle Libre 3 Sensors After Low Glucose Reading Concerns
U.S. — According to the U.S. Food and Drug Administration, healthcare company Abbott has initiated a medical device correction involving certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitoring sensors distributed in the United States.
The company announced the action on November 24, 2025, with the FDA publishing the notice on January 15, 2026. Abbott says internal testing revealed that a subset of sensors may provide incorrect low glucose readings, which could potentially lead users to make unsafe treatment decisions.
Health officials warn that undetected false low readings over time could cause people living with diabetes to consume excessive carbohydrates or delay or skip insulin doses. These actions may pose serious health risks, including injury, severe complications, or in rare cases, death.
Abbott confirmed the issue was traced to one specific production line among several that manufacture Libre 3 and Libre 3 Plus sensors. The company says the manufacturing issue has been identified and resolved and that sensor production is continuing without expected supply disruptions.
Approximately 3 million sensors in the U.S. are included in this medical device correction, though Abbott estimates about half of those have already expired or been used. Worldwide, the company has received reports of 736 severe adverse events, including seven deaths, none of which occurred in the United States.
What Consumers Should Do
Abbott is urging consumers currently using FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensors to check whether their device is affected by visiting:
👉 https://www.FreeStyleCheck.com
The website allows users to confirm whether their sensor is impacted and request a free replacement. Abbott says any affected sensors will be replaced at no cost.
If a sensor is confirmed as potentially impacted, consumers are advised to stop using the sensor immediately and dispose of it. When glucose readings do not match symptoms or expectations, users should rely on a traditional blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader before making treatment decisions.
Abbott’s customer service is available at 1-833-815-4273, seven days a week from 8 a.m. to 8 p.m. Eastern Time. Live chat support is also available 24/7 at:
https://www.freestyle.abbott/us-en/support/contact-us.html
Products Not Affected
Abbott says FreeStyle Libre 3 readers and mobile apps are not impacted, and no other Libre products — including FreeStyle Libre 14 Day, Libre 2, Libre 2 Plus, Libre Pro sensors, or Abbott biowearables — are affected by this action.
Abbott is also issuing similar medical device corrections in other countries where Libre 3 and Libre 3 Plus sensors are distributed.
As with all FDA safety notices, consumers are encouraged to remain vigilant and consult healthcare providers if they have concerns about their glucose readings or treatment decisions.
Stay tuned to iSkyNews.com for any updates and more local and national news.
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