Abbott says no FreeStyle Libre readers being physically recalled

After the FDA yesterday posted a notice regarding FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Management Systems’ reader devices, Abbott issued the following statement to The Fly: "No readers are being physically recalled and customers can continue to safely use their readers with the Abbott-provided USB cable and power adapter. Customers do not need to return their readers. The steps outlined at www.FreeStyleBattery.com provide guidance on how to properly store, charge and use a reader and its accompanying USB cable and power adapter. Similar to mobile phones and many other handheld electronic devices, most continuous glucose monitoring system readers or receivers use rechargeable lithium-ion batteries. While rechargeable lithium-ion batteries are generally safe when used properly, they may present a fire hazard if they are damaged or used improperly. We’ve been communicating with people who use our FreeStyle Libre family of readers since February to ensure they know how to safely store, charge and use our readers and have set up a website www.FreeStyleBattery.com where they can learn more. This notice does not impact people who do not own a reader or only use FreeStyle Libre portfolio sensors with our mobile apps." The FDA recall notice, dated April 6, which states that the FDA has identified this as a Class I recall, "the most serious type of recall," can be found here.