The issue affects more than 4.2 million devices across the US, the FDA says.
on its FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers in the US because of reports from some users that the readers' lithium-ion batteries swelled, overheated and, in some cases, generated sparks or even caused a fire.
provide guidance on how to properly store, charge and use a reader and its accompanying USB cable and power adapter," Abbott told CNN in an email Friday.People with diabetes use glucose monitors to check their blood sugar levels because of problems with how their body makes or uses insulin, a hormone that helps blood sugar enter cells, where it is used for energy. Without insulin, sugar can build up in the bloodstream and break down the body's own fat and muscle.
The monitor used with the FreeStyle Libre line uses lithium-ion batteries similar to those in a mobile phone. The battery is recharged with a yellow USB cable that Abbott provides with the equipment and which limits electric current to safely charge the battery. Use of other USB cables or power adapters, along with misuse of the equipment such as damage or exposure to liquids, may increase the risk of fire, the FDA's recall says.
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