Z-0734-2024 Class II
FDA device recall Z-0734-2024 was initiated by Abbott Diabetes Care, Inc. on February 9, 2023 and is designated Class II. 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 rea… Affected quantity: 45,173.
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- February 9, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,173
Product Description
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
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 Pattern
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.
Code Information
UDI-DI: 00357599816001, Software v.3.4.0 and below