Abbott issues voluntary correction for FreeStyle Libre devices
By HME News Staff
Updated 10:26 AM CDT, Fri April 7, 2023
ABBOTT PARK, Ill. – Abbott in February initiated a voluntary medical device correction for its FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 readers in the United States due to a limited number of reports (0.0017%) over several years of their lithium-ion batteries swelling, infrequently overheating or, in very rare cases, sparking or catching 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 company, however, has outlined steps at ww.FreeStyleBattery.com to provide guidance on how to properly store, charge and use a reader and its accompanying USB cable and power adapter. Abbott has been notifying customers of this matter since February through a variety of communication methods, including 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.
Comments