Abbott recalls some of the readers used with Libre Glucose Monitoring Systems for risk of fire
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
Product Name: FreeStyle Libre Flash Glucose Monitoring System, FreeStyle Libre 14 day Flash Glucose Monitoring System, FreeStyle Libre 2 Flash Glucose Monitoring System
Product Models: all Reader serial numbers
Distribution Dates: Beginning November 2017 – February 2023
Devices Recalled in the U.S.: 4,210,785
Date Initiated by Firm: February 13, 2023
Device Use
The FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Monitoring Systems are intended to provide continuous monitoring of glucose levels. These devices help people manage diabetes by detecting trends and tracking patterns in glucose levels so treatment can be adjusted as needed. They are used in place of other blood glucose meters, are for single patient use, and require a prescription.
Reason for Recall
Abbott is recalling the FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Management Systems because the systems' reader devices, which use rechargeable lithium-ion batteries, may get extremely hot, spark, or catch on fire if not properly stored, charged, or used with its Abbott provided USB cable and power adapter. This does not affect any of the FreeStyle Libre family of sensors.
The potential for overheating, spark or fire may occur when charging the Reader with non-Abbott adapters or non-Abbott USB cables along with misuse of the Reader and its components. Examples of misuse include exposure to liquids, damage, and introduction of foreign material into the ports.
The Abbott-provided USB cable and power adapter limit the current to safely charge the battery, whereas USB cables and power adapters manufactured by a third party may allow much higher power, increasing the risk of fire.
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. Additionally, users may delay or miss a critical diabetes treatment if the system cannot be used after is damaged by extreme heat.
Abbott reports 206 incidents, including at least seven fires, one injury, and no deaths involving this issue.
Who May be Affected
People who monitor their glucose levels using the FreeStyle Libre, Libre 14 day, or Libre 2 Glucose Monitoring Systems.
Health care providers with patients who use FreeStyle Libre, Libre 14 day, or Libre 2 systems to monitor their glucose levels.
What to Do
On February 13, 2023, Abbott sent some users of the FreeStyle Libre family of Readers an Urgent Medical Device Correction letter.
The FDA recommends:
Stop using the 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
If the Reader is no longer able to hold a charge (for example, does it turn off unexpectedly or immediately after charging?)
If the Reader is damaged or a replacement USB cable or power adapter are needed, call Abbott's Customer Service at 1-855-632-8658 to request a replacement.
To avoid the potential for battery swelling, leakage, extreme overheating and/or fire, Abbott recommends the following:
Charge the Reader battery by ONLY using the Abbott supplied USB cable and adapter (charger). Photos are included on www.FreeStyleBattery.comExternal Link Disclaimer to help identify Abbott cables and adapters.
DO NOT expose the Reader, power adapter or yellow USB cable to water or other liquids.
Store the Reader between -4 °F and 140 °F.
DO NOT place the Reader in water or other liquids.
Avoid getting dust, dirt, blood, control solution, water, bleach, or any other substance in the test strip or USB port.
Review the revised user guide and labeling here at www.freestyle.abbott/us-en/supportExternal Link Disclaimer
Visit www.FreeStyleBattery.com to follow steps to perform a Reader Test to determine if your current Reader needs to be replaced
Contact Information
Users with questions about this recall should contact Abbott Customer Service at 1-855-632-8658, available 7 days a week from 8AM to 8PM Eastern Time, excluding major holidays.
Additional Resources
Medical Device Recall Database Entry
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.