FDA Device recall Z-0734-2024
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
- FDA Device
- Class II
- completed
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class II recall of FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System by Abbott Diabetes Care, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0734-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-02-09 |
| Published | 2024-01-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Diabetes Care |
| Distribution | US |
Product
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Reason
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.
Identifiers
| code_info | UDI-DI: 00357599816001, Software v.3.4.0 and below |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0734-2024%22
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