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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.comExternal Link Disclaimer 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.
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