FDA Medical Device Recalls (openFDA)
BioMerieux SA: 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.
- Recall number
- Z-2225-2021
- Recalling firm
- BioMerieux SA
- 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.
- Status
- Terminated
- Initiated
- 2021-06-22
- Posted
- not on file
- Terminated
- 2023-02-06
- Reason
- Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
- Root cause
- Software design
- Action
- bioMerieux in North Carolina issued an 'URGENT PRODUCT CORRECTION NOTICE FSCA 5173-1 - MAY 2021" to their U.S. consignees on 6/22/2021 via email or overnight mail. The notice described the issue and listed the criteria that would result in the MYLA system being impacted. If all of the criteria are confirmed on the MYLA system, then the system will be impacted by this FSCA and the consignee is instructed to stop using the user scripting rules that change the value in field a4 (Final Category) and update the MYLA application to version 4.8.2.
- Quantity
- 248 systems
- Distribution
- Distribution in the U.S. was nationwide. There was also military and government distribution.
- Lot, serial or model codes
- MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 1000611339
- Firm city
- Marcy L'Etoile
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28