Abbott Diabetes Care, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0734-2024)
See the recall detail below. You can also see other recalls from the same firm in 2024.
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Class II
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.
UDI-DI: 00357599816001, Software v.3.4.0 and below
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.
Voluntary: Firm initiated