Abbott is initiating a medical device correction for certain Readers in the FreeStyle Libre family of products including FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers.
Like cell phones and many other handheld electronic devices, our Readers use lithium-ion batteries. While lithium-ion batteries are generally safe when used properly, they may present a fire hazard if they are damaged.
This notice is being communicated as a voluntary Medical Device Correction to provide information about risks associated with the lithium-ion batteries contained only in the FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers.
We have received reports from some users regarding Reader issues, including battery swelling, and in rare cases extreme overheating which may pose a fire hazard. Our investigation has determined that using a charging cable or power adapter that was not included with your Readers may increase the risk of a fire hazard.