FDA Device recall Z-0084-2022
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
- FDA Device
- Class II
- terminated
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System by Biomerieux, citing under certain conditions, there is a risk for a false negative result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0084-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-02 |
| Published | 2021-10-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Reason
Under certain conditions, there is a risk for a false negative result.
Identifiers
| code_info | MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0084-2022%22
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