Recall Announcement: Abbott FreeStyle Libre 3 Continuous Glucose Monitoring Sensors

This recall pertains to the removal of specific devices from usage or sale, excluding the FreeStyle Libre 3 reader or app. The FDA classified this recall as the most severe category, stating that ongoing use may lead to serious injuries or fatalities.

Product Details

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

Recommended Actions

• Users of FreeStyle Libre 3 sensors should verify the serial numbers to determine if their sensor is affected.
• Distributors should inspect their inventory to identify any remaining affected sensors.
• Cease usage and distribution of any impacted sensors immediately.
• Dispose of the affected sensors responsibly.

On July 24, 2024, Abbott Diabetes Care Inc notified impacted customers with an Urgent Medical Device Recall outlining these steps:

• Cease usage and safely dispose of affected sensors.
• Request replacements for affected sensor(s) via this link.
  • Choose “CONFIRM SENSOR SERIAL NUMBER” and input a valid serial number.
  • Customers with affected sensors will be prompted to provide contact details for a no-cost replacement.
• If there are any discrepancies between sensor glucose readings and physical symptoms, validate the reading with a fingerstick test using any glucose meter.
  • The FreeStyle Libre 3 Reader’s built-in blood glucose meter is not impacted by this recall and may be utilized as needed.

Reason for Recall

Abbott Diabetes Care Inc is initiating a recall of the FreeStyle Libre 3 sensors after identifying that a limited number may yield erroneous high glucose readings, posing a potential health risk for diabetic individuals.

The use of affected products may result in serious adverse health outcomes, including severe hypoglycemia, which could lead to central nervous system issues, unconsciousness, seizures, coma, irreversible brain damage, or death.

Two injuries have been reported, with no fatalities recorded.

Device Purpose

The FreeStyle Libre 3 Continuous Glucose Monitoring System is designed for real-time glucose level monitoring. It assists individuals in managing diabetes by identifying trends and tracking glucose level fluctuations for appropriate treatment adjustments. It is intended for single-patient use and necessitates a prescription.

Contact Information

U.S. customers requiring further information about this recall can reach Abbott Diabetes Care Inc customer service at 1-833-815-4273.

Additional FDA Resources

Company Resource Links

Unique Device Identifier (UDI)

The UDI serves to identify specific medical devices marketed in the U.S., tracking them throughout production, distribution, and patient utilization. This system improves the accuracy of adverse event reporting and allows for swift identification and rectification of device-related issues.

Reporting Issues

Healthcare professionals and consumers can report adverse reactions or quality concerns associated with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.