# FDA recall Z-1640-2022

> **bioMerieux, Inc.** · Class II · device recall initiated 2022-07-13.

## Product

VITEK 2 / MYLA    VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03  MYLA Software versions V4.8 and V4.9

## Reason for recall

There are 7 reported software anomalies that may affect use of the device.

## Distribution

International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.

## Key facts

- **Recall number:** Z-1640-2022
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-13
- **Report date:** 2022-09-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1640-2022

## Citation

> AI Analytics. FDA recall Z-1640-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1640-2022. Source: US FDA. Licensed CC0.

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