Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 App, part of Continuous Glucose Monitoring
Recalled Product
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Hazard / Issue
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.
Issued by
FDA
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