The FDA today issued a notice classifying a recall of Abbott (NYSE:ABT) FreeStyle Libre readers as Class I, the most serious kind.
Earlier this week, Abbott initiated a voluntary medical device correction to emphasize instructions for FreeStyle Libre continuous glucose monitor (CGM) readers. The company said it received a limited number of global reports (0.0017%) from users over several years saying their reader’s lithium-ion battery swelled or infrequently overheated. In very rare cases, users reported that the battery sparked or caught fire.
No readers are being physically recalled. Customers can continue to safely use their readers with the Abbott-provided USB cable and power adapter. Customers do not need to return their readers.
Today’s FDA notice offers more detail into which devices the warning affects and how far-reaching it is. It spans the FreeStyle Libre Flash, FreeStyle Libre 14-day and the FreeStyle Libre 2 Flash. All affected products are glucose monitoring systems. The notice does not affect any of the FreeStyle Libre family of sensors.
All reader serial numbers fall under the reach of the warning. Abbott distributed affected devices between November 2017 and February 2023. It initiated the action on Feb. 13, 2023, and it affects 4,210,785 devices in the U.S. to date.
Abbott reports 206 incidents, including at least seven fires, one injury and no deaths involving this issue.
Details of the Abbott FreeStyle Libre reader warning
The affected devices provide continuous monitoring of glucose levels. The devices help users detect trends and track patterns in glucose levels so they can adjust treatment as needed. Used in place of other blood glucose meters, they require a prescription.
According to the FDA notice, all affected devices’ readers use rechargeable lithium-ion batteries. They may get extremely hot, spark, or catch on fire if not properly stored, charged or used with the Abbott-rovided USB cable and power adapter.
The potential for such an occurrence may come when charging with non-Abbott adapters or non-Abbott USB cables. This goes along with misuse of the reader and its components. According to the FDA notice, this can include exposure to liquids, damage, and introduction of foreign material into the ports. Abbott-provided cables and adapters limit the current to safety charge the battery. Third-party cables and adapters may allow higher power, increasing the risk of fire.
If not properly stored, charged or used with Abbott-provided materials, the reader may expose users to extream heat and/or fire. This can cause serious injury or death. Additionally, users may delay or miss a critical diabetes treatment if the system becomes unusable due to heat-related damage.
Statement from Abbott
An Abbott spokesperson shared the company’s statement on the warning:
“No readers are being physically recalled and customers can continue to safely use their readers with the Abbott-provided USB cable and power adapter. Customers do not need to return their readers. The steps outlined at www.FreeStyleBattery.com provide guidance on how to properly store, charge and use a reader and its accompanying USB cable and power adapter.
“Similar to mobile phones and many other handheld electronic devices, most continuous glucose monitoring system readers or receivers use rechargeable lithium-ion batteries. While rechargeable lithium-ion batteries are generally safe when used properly, they may present a fire hazard if they are damaged or used improperly.
“We’ve been communicating with people who use our FreeStyle Libre family of readers since February to ensure they know how to safely store, charge and use our readers and have set up a website www.FreeStyleBattery.com where they can learn more. This notice does not impact people who do not own a reader or only use FreeStyle Libre portfolio sensors with our mobile apps.”
This story was updated to clarify that no readers are physically being recalled.