Abbott has initiated a recall for readers for its FreeStyle Libre glucose monitoring systems, which are at risk of catching fire if improperly stored or charged, according to the Food and Drug Administration.
The agency categorized the recall as Class I, the most serious category of problems with medical devices, which can cause serious injury or death. Abbott noted that users do not need to send the devices back to the company, but can continue to use them, as long as they use chargers and cables supplied by Abbott with the device.
Abbott said the readers, which are handheld devices that take information from a continuous glucose monitor attached to a patient’s body, use rechargeable lithium-ion batteries. Those batteries may get extremely hot, spark, or catch fire if not properly stored, charged, or used with the USB cable and power adapter that Abbott provided.
“The Reader, if not properly stored, charged, or used with its Abbott provided USB cable and power adapter, may expose users to extreme heat and/or fire which can cause serious injuries or death,” the FDA wrote in its recall notice.
The issue affects readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems, but does not affect the sensors, which are worn on the body. The recall affects 4.2 million units made between November 2017 and February 2023.
Abbott reported 206 incidents — including at least seven fires, one injury and no deaths — to the FDA. It warned that if a reader is damaged by high heat, a user may delay or miss a critical diabetes treatment.
Abbott first warned users of the danger on Feb. 13, and on April 3 made the warning public. The FDA’s recall was issued on Thursday. In its statement, Abbott noted that over several years, only 0.0017% of users reported problems with the batteries. There was no indication of what prompted the FDA to label the problem a Class I recall.
The company has set up a special website with more information for people who use the FreeStyle glucose readers.
Abbott said that users can replace the reader with a smartphone app.
Updates with additional information from Abbott to clarify that users do not need to return their readers to the company, and may continue to use them.