FDA Device recall Z-2225-2021
MYLA software
- FDA Device
- Class II
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of MYLA software by Biomerieux, citing software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2225-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-22 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
Reason
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Identifiers
| code_info | MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975. |
|---|
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-2225-2021%22
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