Abbott has issued a safety notification regarding the readers used as part of the FreeStyle Libre® family of products, specifically the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems (all reader serial numbers).
The FreeStyle Libre systems consist of a handheld reader that collects real-time glucose readings directly from the sensor that is inserted just under the skin. The reader uses lithium-ion batteries, which have the potential for battery swelling, leakage or extreme overheating if not properly stored, charged, or used with the Abbott-provided yellow USB cable and power adapter. Though rare, battery issues have been reported worldwide, and in a few instances, have resulted in fires.
In February 2023, Abbott initiated a voluntary medical device correction to emphasize instructions for its readers. At this time, no readers are being recalled; customers should continue to use them with the Abbott-provided USB cable and power adapter.
Abbott’s recommendations to prevent battery-related issues with the readers include:
- Using only the Abbott-supplied yellow USB cable and adapter for charging;
- Keeping the reader, power adaptor and USB cable away from water or other liquids;
- Storing the reader between -4 °F and 140 °F;
- Keeping the reader clean by avoiding dust, dirt, blood, control solution, water, bleach or any other substance in the test strip or USB port.
Additional guidance is available at www.FreeStyleBattery.com. The website includes a short survey that can help a user determine whether the reader needs to be replaced. This safety notification does not affect any of the FreeStyle Libre family of sensors.
Abbott issues safety notification for FreeStyle Libre® family of readers in the U.S. News release. Abbott. April 5, 2023. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-issues-safety-notification-freestyle-librer-family-readers-us.