Medical Device Recall: FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Abbott Diabetes Care, Inc. · February 9, 2023
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.
States Affected
NATIONWIDE
Quantity Affected
45,173
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0734-2024
Status: completed
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.