FreeStyle Libre 3 App, part of Continuous Glucose… recallZ-0734-2024 · Abbott Diabetes Care, Inc. · initiated Feb 9, 2023
Class II Completed All recalls posted in January 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Diabetes Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0734-2024
- Recall class
- Class II
- Status
- Completed
- Initiated by the company
- Feb 9, 2023
- Posted by the FDA
- Jan 16, 2024
- Recalling firm
- Abbott Diabetes Care, Inc.
- Quantity
- 45,173
- Product code
- QLG
- FDA submissions
- K213996
- 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.
Product description
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Code information (models, lots, serial numbers)
UDI-DI: 00357599816001, Software v.3.4.0 and below
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FreeStyle Libre 3 App 72075-01Abbott Diabetes Care Inc · Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems1 recall23 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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