# FDA recall Z-0734-2024

> **Abbott Diabetes Care, Inc.** · Class II · device recall initiated 2023-02-09.

## Product

FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

## 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.

## Key facts

- **Recall number:** Z-0734-2024
- **Recalling firm:** Abbott Diabetes Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-02-09
- **Report date:** 2024-01-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alameda, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0734-2024

## Citation

> AI Analytics. FDA recall Z-0734-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0734-2024. Source: US FDA. Licensed CC0.

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