Abbott Diabetes Care, Inc.: FreeStyle Libre 3 Sensors Recalled for Erroneously High Glucose Readings

Agency Publication Date: August 27, 2024

Summary

Abbott is recalling 8,174 FreeStyle Libre 3 Sensors, which are components of the FreeStyle Libre 3 Continuous Glucose Monitoring System. These sensors can report inaccurate higher-than-actual glucose levels, which may lead patients to take too much insulin or fail to notice dangerously low blood sugar (hypoglycemia). Consumers should contact their healthcare provider for guidance on managing their glucose monitoring and contact Abbott for further instructions regarding this recall.

Risk

The sensors may provide erroneously high glucose results, leading users to administer excessive insulin correctional doses or causing them to miss life-threatening hypoglycemia. This defect can result in severe health consequences including loss of consciousness, seizure activity, coma, permanent neurological damage, or death.

What You Should Do

Check your FreeStyle Libre 3 Sensor packaging for REF number 72081-01 and UDI-DI 00357599818005.
Identify if your sensor is part of the affected batches by checking the Lot/Serial Numbers on the package. Affected numbers include thousands of codes starting with prefixes like T60001948, T60001966, and T60001969.
If you are using an affected sensor, contact your healthcare provider immediately to discuss your blood glucose monitoring routine and treatment plan.
Contact Abbott Diabetes Care, Inc. for specific instructions regarding the return or replacement of your affected sensors.
Report any adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch program.
For further questions or to confirm if your specific serial number is included, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Healthcare provider consultation and manufacturer contact

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: FreeStyle Libre 3 Sensors, REF: 72081-01

Model / REF:

72081-01

UPC Codes:

00357599818005

Lot Numbers:

T60001948 (followed by specific serial codes)

T60001966 (followed by specific serial codes)

T60001969 (followed by specific serial codes)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95047

Status: Active

Manufacturer: Abbott Diabetes Care, Inc.

Sold By: authorized medical supply distributors; pharmacies

Manufactured In: United States

Units Affected: 8,174

Distributed To: New Jersey, Pennsylvania, Ohio, Texas, Virginia, California, New York, Florida, Washington, Mississippi, Minnesota, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your FreeStyle Libre 3 Sensor packaging for REF number 72081-01 and UDI-DI 00357599818005.

Identify if your sensor is part of the affected batches by checking the Lot/Serial Numbers on the package. Affected numbers include thousands of codes starting with prefixes like T60001948, T60001966, and T60001969.

If you are using an affected sensor, contact your healthcare provider immediately to discuss your blood glucose monitoring routine and treatment plan.

Contact Abbott Diabetes Care, Inc. for specific instructions regarding the return or replacement of your affected sensors.

Report any adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch program.

For further questions or to confirm if your specific serial number is included, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.