FDA Medical Device Recalls (openFDA)
BioMerieux SA: MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
- Recall number
- Z-0084-2022
- Recalling firm
- BioMerieux SA
- Product
- MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
- Status
- Terminated
- Initiated
- 2021-09-02
- Posted
- not on file
- Terminated
- 2026-03-09
- Reason
- Under certain conditions, there is a risk for a false negative result.
- Root cause
- Software design
- Action
- A customer letter was issued to impacted subsidiaries and distributors on 09/08/2021. The letter includes instructions that the customer verify that they operate under the specific conditions required for the anomaly to occur: You are using MYLA (V4.7, V4.7.1, V4.8, V4.8.1 or V4.8.2) in conjunction with BCI Connect AND You are managing Blood Culture analyses on BACT/ALERT VIRTUO connected to MYLA AND Your Blood Culture workflow is based on 2 or more bottles with the same specimen (same specimen/laboratory id) AND You are using the LIS capability to send Blood Culture requests containing the incubation expected duration (MTT) AND You are sending other requests than Blood Culture (Offline SU, ID,) on the same specimen than the one used for BC note: this condition is applicable only if it occurs after the previous ones, chronologically speaking - If the answer to ALL of the above questions is yes, then the customer must contact their bioMerieux representative for help to implement a workaround that should be used until MYLA version 4.9 is available. If the answer to any of the above question is no, the customer will not be impacted by this anomaly. The firm issued an updated Field Safety Corrective Action, FSCA #5308-2, on 9/29/2021 to subsidiaries and distributors which replaced FSCA #5308-1 to revise references in the FSCA document to only include the references of the impacted software. The firm added Annex I to the enclosed customer letter to be issued by the subsidiaries/distributors that provides guidance on how to check the MYLA software version and if BCI connectivity is being used.
- Quantity
- 542 units
- 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.
- Lot, serial or model codes
- MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OUG
- Firm FEI
- 3008237827
- Firm city
- La Balme les Grottes
- 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