Abbott Initiates a Medical Device Correction for Certain Readers from the FreeStyle Libre Family of Products

 

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Abbott is initiating a medical device correction for certain Readers from the FreeStyle Libre family of products.

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.

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 Reader may increase the risk of a fire hazard.

No other Abbott diabetes care products are affected.

To determine if you are impacted, please select your country and language below and follow the steps.

We are working with regulatory bodies globally. Please check back periodically to see if your country is impacted.

Select your country & Language

ADC-70627 v1.0

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