Abbott has announced a voluntary correction for a number of FreeStyle Libre® 3 sensors distributed in the U.S. in early May 2024. This correction affects only the sensors, leaving the FreeStyle Libre 3 reader and app unaffected.
Internal tests revealed that some sensors from three specific lots could give inaccurate high glucose readings. These errors could lead to potential health risks for individuals with diabetes, including incorrect insulin usage.
Abbott advises users to check their sensor lot numbers and follow the correction guidelines to ensure safe and accurate glucose monitoring.
This issue affects FreeStyle Libre 3 sensors from among those within the following three lot numbers:
- T60001948
- T60001966
- T60001969
If consumers have FreeStyle Libre 3 sensors from other lots, there is no need to take action and they can continue to use their sensors. There is no impact for users who live outside of the U.S. or use other FreeStyle Libre products (FreeStyle Libre 14 day, FreeStyle Libre 2, or FreeStyle Libre 2 Plus).
How to Identify Lot or Serial Number
If the sensor is still in the package, the lot and serial number (identified as “SN”) can be found on the bottom of the carton’s packaging.
If the sensor is currently in use or may have already been used, the serial number can be displayed within the FreeStyle Libre 3 app or reader. More detailed instructions on locating the serial number can be found by visiting www.FreeStyleConfirm.com.
Checking if the Sensor is Affected
If the consumer’s product lot number is listed above, they need to visit www.FreeStyleConfirm.comExternal Link Disclaimer, select “Confirm Sensor Serial Number,” and enter their serial number to confirm whether their sensor is affected by this voluntary medical device correction. Consumers wearing an affected FreeStyle Libre 3 sensor should immediately discontinue use and dispose of any affected sensors in their possession. If the consumer’s sensor is impacted they will need to enter their contact information so Abbott can send them a replacement sensor at no charge.
“We sincerely regret the disruption this may have on our customers,” said Jared Watkin, executive vice president of Abbott’s diabetes care business. “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.”
Consumers are instructed to conduct a fingerstick test using any blood glucose meter if they experience symptoms that do not match the sensor glucose reading or suspect the reading may be inaccurate. The built-in blood glucose meter in the FreeStyle Libre 3 reader may be used to check glucose at any time.
Consumers can visit www.FreeStyleConfirm.comExternal Link Disclaimer to learn more or call customer service at 1-833-815-4273, available seven days a week from 8 a.m. to 8 p.m. Eastern Time, excluding holidays.