ABBOTT PARK, Ill., April 3, 2023 – Abbott initiated a voluntary medical device correction in February to emphasize instructions for its FreeStyle Libre®, FreeStyle Libre® 14 day and FreeStyle Libre® 2 Readers in the United States due to a limited number of reports worldwide (0.0017%) from users over several years that their reader’s lithium-ion battery swelled, infrequently overheated or, in very rare cases, sparked or caught fire. No Readers are being physically recalled and customers can continue to use their Readers with the Abbott-provided USB cable and power adapter. The steps outlined below and at www.FreeStyleBattery.com provide guidance on how to properly store, charge and use a Reader and its accompanying USB cable and power adapter.
The Reader is a small handheld device that collects real-time glucose readings directly from a sensor worn on the back of a person’s upper arm, allowing them to manage their diabetes by seeing their glucose readings on a screen. If users prefer, they can also use a compatible smartphone app 1 to receive their glucose data. To switch to the app, the user must start a new sensor.
To avoid the potential for battery swelling, leakage, extreme overheating and/or fire, Abbott recommends the following:
Abbott has been notifying customers of this matter since February through a variety of communication methods, including by email and letters. This communication to customers was done voluntarily, and the U.S. Food and Drug Administration has been informed.
Like mobile phones and many other handheld electronic devices, the FreeStyle Libre family of Readers use lithium-ion batteries, which are safe when used per instructions outlined at www.FreeStyleBattery.com.
Since FreeStyle Libre Readers launched in the U.S. in 2017, there have been no reported incidents that have caused serious adverse health consequences or death due to this issue. As previously communicated to Reader customers, if a Reader is stored, charged and used properly then risks are mitigated.
If customers have questions or want to learn how to test their Reader as well as properly store, charge and use their Reader and its USB cable and power adapter, they’re encouraged to review the Perform a Reader Test section of the Reader User Manual, visit www.FreeStyleBattery.com, or contact Abbott’s Customer Service at 1-855-632-8658. Customers may also contact Abbott’s Customer Service if they want replacement accessories. Agents are available to help customers seven days a week from 8 a.m. to 8 p.m. Eastern Time, excluding major holidays.
This medical device correction does not affect any of the FreeStyle Libre family of sensors. For more information on how to perform a reader test and reduce risks, visit www.FreeStyleBattery.com.
Important Safety Information
Failure to use FreeStyle Libre system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us for safety info.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.