FDAFDA · Food and drugs·Recall number Z-0734-2024
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Published January 24, 2024 · Recall initiated: February 9, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Diabetes Care, Inc.
- Distributor
- 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.
- Lot
- UDI-DI: 00357599816001, Software v.3.4.0 and below
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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