Abbott Diabetes Care, Inc.: FreeStyle Libre 3 App Recalled for Potential Signal Loss on Android 13

Agency Publication Date: January 16, 2024

Summary

Abbott Diabetes Care, Inc. is recalling the FreeStyle Libre 3 App, part of its Continuous Glucose Monitoring System, when used on smartphones running the Android 13 operating system. This recall affects approximately 45,173 units of software version 3.4.0 and below because the app may experience extended periods of signal loss. This connection failure can prevent the system from delivering glucose readings or sounding critical alarms. Consumers should contact their healthcare provider or Abbott Diabetes Care for technical guidance and to ensure their software is updated.

Risk

The app may lose its connection to the glucose sensor for long periods, preventing users from receiving alerts for high or low blood sugar. This lack of notification could lead to undetected glucose extremes and delayed medical treatment, such as failing to take insulin or glucose when necessary.

What You Should Do

Check your smartphone to see if it is running the Android 13 Operating System and verify if you are using the FreeStyle Libre 3 App.
Verify the software version of your FreeStyle Libre 3 App by looking for version 3.4.0 or below associated with UDI-DI 00357599816001.
Be aware that you may experience extended periods of signal loss where glucose readings and alarms are unavailable; if this occurs, use a backup blood glucose meter to make treatment decisions.
Contact your healthcare provider to discuss how this signal loss might affect your diabetes management plan.
Contact Abbott Diabetes Care, Inc. at their Alameda, California headquarters or through their official support channels to receive updated instructions or software information.
For additional questions or to report issues, 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

Manufacturer notification and technical guidance

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

Affected Products

Product: FreeStyle Libre 3 App (Continuous Glucose Monitoring System)

Model / REF:

Software v.3.4.0 and below

Lot Numbers:

UDI-DI: 00357599816001

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93393

Status: Resolved

Manufacturer: Abbott Diabetes Care, Inc.

Sold By: Authorized medical distributors; App stores

Manufactured In: United States

Units Affected: 45,173

Distributed To: New York, California, New Jersey, Utah, Pennsylvania, Mississippi, Ohio, Texas, Minnesota, Florida, Louisiana, Nebraska, Michigan, Virginia, North Carolina, Massachusetts, Indiana, South Carolina, Iowa

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 · 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

What You Should Do

Check your smartphone to see if it is running the Android 13 Operating System and verify if you are using the FreeStyle Libre 3 App.

Verify the software version of your FreeStyle Libre 3 App by looking for version 3.4.0 or below associated with UDI-DI 00357599816001.

Be aware that you may experience extended periods of signal loss where glucose readings and alarms are unavailable; if this occurs, use a backup blood glucose meter to make treatment decisions.

Contact your healthcare provider to discuss how this signal loss might affect your diabetes management plan.

Contact Abbott Diabetes Care, Inc. at their Alameda, California headquarters or through their official support channels to receive updated instructions or software information.

For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.