The company distributed the affected sensors during the first half of May 2024. Abbott did not disclose the number of sensors affected but said the recall affects a small subset of FreeStyle Libre 3 sensors. Those sensors fall within three lot numbers: T60001948, T60001966 and T60001969.
Abbott’s FreeStyle Libre 3 system—its latest-generation system—originally received FDA clearance in 2022. It includes a sensor, reader and app. This recall impacts the sensor only, not the system’s reader and app.
Internal testing determined that some sensors from the three affected lots may provide incorrect high glucose readings, according to a news release. If undetected, incorrect readings could pose a potential health risk for people living with diabetes. It can lead to incorrect treatment decisions, such as taking insulin when not required.
Abbott said that if consumers have FreeStyle Libre 3 sensors from other lots, they have no need to take action. They can continue using their sensors. The recall does not extend to those who live outside the U.S. or use other Libre products.
If customers experience symptoms that don’t match their glucose reading or suspect inaccuracy, they are instructed to conduct a fingerstick test using a blood glucose meter. Libre 3’s reader has a built-in blood glucose meter they can use at any time.
“We sincerely regret the disruption this may have on our customers,” said Jared Watkin, EVP of Abbott Diabetes Care. “We’re actively working with the U.S. 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.”
Customers can learn more about how to check their sensor HERE.
