# FDA recall Z-0260-2020

> **LABSTYLE INNOVATIONS** · Class II · device recall initiated 2019-08-29.

## Product

Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

## Reason for recall

The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.

## Distribution

Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.

## Key facts

- **Recall number:** Z-0260-2020
- **Recalling firm:** LABSTYLE INNOVATIONS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-29
- **Report date:** 2019-11-06
- **Termination date:** 2020-05-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ramat Gan, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0260-2020

## Citation

> AI Analytics. FDA recall Z-0260-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0260-2020. Source: US FDA. Licensed CC0.

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