FreeStyle Libre Glucose Monitoring Systems Recall Investigation

CSK&D is investigating a potential class action lawsuit against Abbott Laboratories related to an alleged safety defect with FreeStyle Libre Glucose Monitoring Systems that are used by diabetes patients to help them monitor their blood glucose levels. Abbott Laboratories recently issued a recall because of a safety issue with the lithium ion batteries used in these devices.

According to the FDA, if these devices are not properly stored or charged, the batteries powering these devices may swell and get extremely hot, spark, or catch fire, which may expose users to serious injuries or death.  Additionally, users may delay or miss a critical diabetes treatment if the system cannot be used after it is damaged by extreme heat. Abbott reports 206 incidents, including at least seven fires and one injury involving this alleged defect.

The recall incudes the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Glucose Monitoring Systems.

Owners are being advised to STOP using the affected FreeStyle Glucose Monitoring Systems and switch to a back-up method if:

• You do not have the Abbott provided USB cable and power adapter (charger);
• The Reader appears damaged or cracked;
• If there is visible swelling of the Reader;
• If the Reader gets too hot to hold; and
• If the Reader is no longer able to hold a charge (for example, does it turn off unexpectedly or immediately after charging).

If you own one of the products affected by the recall, please fill out the form below.