Abbott has announced a voluntary medical device correction for a limited number of FreeStyle Libre 3 sensors in the US.
The voluntary correction is intended for the sensors distributed in the first half of May 2024. This is due to the possibility that some of them will provide incorrect high glucose readings.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The FreeStyle Libre 3 system includes a sensor, reader, and app. The correction impacts only the sensor component.
Abbott’s internal testing identified that sensors from three specific lots might give inaccurate readings, potentially leading to inappropriate treatment decisions for individuals with diabetes.
The sensor lots considered for correction include T60001948, T60001966, and T60001969.
The company said that users with sensors from other lots are assured that their devices are safe for continued use.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataAdditionally, the voluntary correction does not impact users outside the US or those using other FreeStyle Libre products.
To determine if a sensor is from an affected lot, users can find the lot and serial number on the bottom of the sensor’s packaging or within the FreeStyle Libre 3 app or reader if the sensor is already in use.
The FreeStyle Libre 3 reader’s built-in blood glucose meter can be used for immediate glucose checks.
Abbott diabetes care business executive vice-president Jared Watkin said: “We sincerely regret the disruption this may have on our customers.
“We’re actively working with the US Food and Drug Administration and distributors, as well as providing information to affected customers, who will receive replacements at no charge as quickly as possible.”
Abbott’s FreeStyle Libre 3 system secured FDA approval in 2022 for diabetic patients aged four years and above.
