FreeStyle Libre 3 App (Abbott) – Signal Loss Risk (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Brand
Abbott Diabetes Care, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00357599816001, Software v.3.4.0 and below
Products Sold
UDI-DI: 00357599816001, Software v.3.4.0 and below
Abbott Diabetes Care, Inc. is recalling FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Ope due to If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected,. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 2/9/23, an Important Message/Communication was sent to customers informing them of the following: If you experience extended periods of signal loss, either of the following actions should allow reconnection: 1) Turn your smartphone's Bluetooth OFF and then ON 2) Turn your smartphone OFF and then ON To be notified if extended periods of signal loss occur: 1) Open your FreeStyle Libre 3 app, navigate to Alarms, and configure your signal loss alarm to be ON with "Override Do Not Disturb" enabled. 2) Please refer to www.FreeStyleAndroid.com for more information on how to configure alarms. On 2/27/23, another Important Message/Communication was sent to customers informing them that updated software version 3.4.2 was available to fix the connection issue. Questions can be directed to Customer Care team at 1-855-632-8658. The team is available 7 days a week from 8 AM to 8 PM Eastern Time, excluding holidays.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026