Abbott Diabetes Care, Inc.: FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

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.

Details from the source

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. Quantity: 45,173 Lot/code info: UDI-DI: 00357599816001, Software v.3.4.0 and below

UPC codes

00357599816001

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.