Abbott Laboratories, the makers of the FreeStyle Libre continuous glucose monitor (CGM), have announced a voluntary Class 1 recall for its readers as a result of a risk of battery failure and fire.

The Problem

A small variety of Libre users have reported that their reader batteries have swelled and/or overheated. In very rare cases, this battery issue has caused fires, and it could conceivably cause serious injuries.

A Class 1 recall is defined by the U.S. Food and Drug Administration (FDA) as “a situation wherein there’s an inexpensive probability that the usage of or exposure to a violative product will cause serious opposed health consequences or death,” though up to now the reader flaw has not caused much serious harm. In its statement with the FDA, Abbott divulged that there have been “206 incidents, including at the least seven fires, one injury, and no deaths involving this issue.”

The issue occurs when the lithium-ion battery is charged with an unapproved cable. Generic charging cables, or cables intended for other devices, can allow an excessive amount of power to flow to the battery. In case your battery gets contaminated in any way, this will create a fireplace risk.

Does the Recall Affect My FreeStyle Libre CGM?

The battery issue affects readers (a handheld device with a digital display), not sensors (the part that you just stick with your body).

FreeStyle Libre readers are dedicated electronic devices that display blood sugar information and could be used with the FreeStyle Libre, FreeStyle Libre 14 Day, and FreeStyle Libre 2 systems. All readers distributed between November 2014 and today share the identical problem.

If you happen to use a smartphone to display your glucose data, relatively than a reader, the recall doesn’t affect you.

I Have a FreeStyle Libre Reader. What Do I Do About It?

There’s likely nothing mistaken with the reader itself: It’s going to proceed to work as intended, and Abbott doesn’t want you to send it in for a substitute if there is no such thing as a sign of harm.

Nevertheless, you ought to be very careful about the way you recharge your reader. You must only use the yellow USB cable and power adapter that got here in the unique packaging together with your reader. If you happen to not have the official cable and power adapter, pictured below, get in contact with Abbott to receive a brand new one.

There’s also a possibility that your reader has already sustained some damage as a result of this issue. To find out if you happen to require a substitute, visit FreeStyleBattery.com and answer the “reader substitute check” questionnaire. In case your reader has any signs of battery issues, Abbott may resolve to send you a brand new one.

In case your reader shows signs of swelling or overheating, stop using it immediately and get in contact with Abbott Laboratories, by visiting FreeStyleBattery.com or calling Abbott’s Customer Service at 1-855-632-8658.