FDA-Device2024-01-24Class II
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Abbott Diabetes Care, Inc.
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.
Sold states
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.
Affected count
45,173
Manufactured in
1360 S Loop Rd, N/A, Alameda, CA, United States
Products
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0734-2024Don't want to check this manually?
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