# FDA recall Z-0084-2022

> **BioMerieux SA** · Class II · device recall initiated 2021-09-02.

## Product

MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System

## Reason for recall

Under certain conditions, there is a risk for a false negative result.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Austria, Australia, Belgium, Canada, Switzerland, Chile, Columbia, Czech Republic, Denmark, Germany, Spain, Finland, France, United Kingdom, Guadeloupe, Hong Kong, Canary Islands, Ireland, India,  Italy, Japan, South Korea, The Netherlands, Norway, Poland, Portugal, Sweden, Singapore, South Africa.

## Key facts

- **Recall number:** Z-0084-2022
- **Recalling firm:** BioMerieux SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-02
- **Report date:** 2021-10-20
- **Termination date:** 2026-03-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** La Balme les Grottes, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0084-2022

## Citation

> AI Analytics. FDA recall Z-0084-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0084-2022. Source: US FDA. Licensed CC0.

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