Continuous Glucose Monitoring (CGM) Sensor Recall: Abbott Diabetes Care Inc Issues Recall for Certain FreeStyle Libre 3 Sensors due to Risk for Inaccurate High Glucose Readings

This recall involves removing certain devices from where they are used or sold, and does not apply to the FreeStyle Libre 3 reader or app. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

Image of the app screen, reader settings, sensor applicator label, and sensor carton

• Product Name: FreeStyle Libre 3 sensor, a component of FreeStyle Libre 3 Continuous Glucose Monitoring System
• Unique Device Identifier (UDI)/Model:   UDI-DI 00357599818005/ Model No 72081-01
• Lot Numbers: 
  • T60001948
  • T60001966
  • T60001969   

What to Do

• Users of FreeStyle Libre 3 sensors should follow the instructions below to check the sensor serial numbers to find out if the sensor is in the affected lot. 
• Distributors of FreeStyle Libre 3 sensors should check their inventory to find out if there are any affected sensors left in their inventory.
• Immediately stop using and distributing any affected sensors.
• Throw affected sensors away. 

On July 24, 2024, Abbott Diabetes Care Inc  sent all affected customers an Urgent Medical Device Recall recommending the following actions:

• Immediately discontinue use and dispose of any affected sensors.
• Request a replacement for any affected sensor(s) by visiting https://www.freestyleconfirm.com/us-en/home.html.
  • Select “CONFIRM SENSOR SERIAL NUMBER” and enter a valid serial number.
  • Customers with impacted sensors will be instructed to enter contact information so a replacement product can be sent at no cost.
• If there are symptoms that do not match the sensor glucose reading or it is suspected that a glucose reading is inaccurate, check the reading by conducting a fingerstick test using any blood glucose meter. 
  • The built-in blood glucose meter in the FreeStyle Libre 3 Reader is not affected by this recall and may be used to check glucose at any time.

Reason for Recall

Abbott Diabetes Care Inc is recalling these FreeStyle Libre 3 sensors after finding that a small number of FreeStyle Libre 3 sensors may provide incorrect high glucose readings, which if undetected may pose a potential health risk for people living with diabetes.

The use of affected product may cause serious adverse health consequences, including severe low blood sugar (hypoglycemia) which can cause central nervous system problems, loss of consciousness, seizures, coma, permanent brain damage, and death.

There have been 2 reported injuries. There have been no reports of death.

Device Use

The FreeStyle Libre 3 Continuous Glucose Monitoring System is intended to provide continuous monitoring of glucose levels. It helps people manage diabetes by detecting trends and tracking patterns in glucose levels so treatment can be adjusted as needed. It is indicated for single patient use, and requires a prescription.

Contact Information

Customers in the U.S. with questions about this recall should contact Abbott Diabetes Care Inc customer service at 1-833-815-4273.

Additional FDA Resources

• FDA’s Enforcement Report
• Medical Device Recall Database

Additional Company Resources

• Press Release: Abbott Issues Voluntary Medical Device Correction for a Small Number of FreeStyle Libre 3 Sensors in the U.S. [07/24/2024]
• Recall Web Page: Urgent Medical Device Correction FreeStyle Libre 3 Sensors
• Customer Notification: Urgent Medical Device Correction FreeStyle Libre 3 Sensors [07/24/2024]

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

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.