FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Summary
The FDA issued a Class II for FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used o by Abbott Diabetes Care, Inc.. Reason: If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected,.
Details
Source
Device Recall
External ID
Z-0734-2024
Action Date
2024-01-24
Status
Completed
Category
device
Product Description
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Lot/Code Info: UDI-DI: 00357599816001, Software v.3.4.0 and below
Quantity Affected: 45,173
Reason for Recall
If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.
Distribution
US Nationwide distribution in the states of NY, CA, NJ, UT, PA, MS, OH, TX, MN, FL, LA, NE, MI, VA, NC, MA, IN, SC, IA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-09
Company
Alameda, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott Diabetes Care, Inc. has 18 FDA actions in our database, including 10 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Diabetes Care, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Diabetes Care, Inc. have FDA actions?
Abbott Diabetes Care, Inc. has 18 FDA actions in our database, including 10 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0734-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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