Abbott is asking users of its FreeStyle Libre 3 diabetes monitors to check the serial numbers of their sensors after the company found that a limited number could provide incorrectly high glucose readings.
According to the company, it has launched a voluntary recall effort after internal testing found issues with three lots of manufactured devices—labeled T60001948, T60001966 and T60001969—with the sensors distributed across the U.S. during the first half of May of this year.
Abbott said the inaccurate readings could pose health risks if they go unnoticed, potentially leading people to take doses of insulin when they are not required.
The company said anyone using an affected sensor should dispose of it immediately and obtain a free replacement and that users should opt for a fingerstick blood sugar test if they feel their symptoms do not match their CGM reading.
“We sincerely regret the disruption this may have on our customers,” Jared Watkin, executive vice president of Abbott’s diabetes care business, said in a statement. “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.”
The FreeStyle Libre 3’s reader and app were unaffected, as were other products in the FreeStyle Libre line. A company spokesperson said Abbott estimates the issue will affect less than 1% of FreeStyle Libre 3 users in the U.S.
Abbott said both lot and serial numbers can be found on the bottom of the original packaging, or, if the sensor is currently in use, the serial number can be pulled up on the system’s app or reader.
If the product carries the same lot number, confirming the serial number through Abbott’s website will determine whether the sensor needs to be replaced.