Z-0084-2022Class II

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

Name: Z-0084-2022 MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Creator: BioMerieux SA
Published: 2021-09-02
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2021-09-02 / Terminated / root cause: software

FDA source

BioMerieux SA began a recall of MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System on 2021-09-02. FDA classified it as Class II and gives the reason as "Under certain conditions, there is a risk for a false negative result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0084-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-02
Posted: 2021-10-08
Terminated: 2026-03-09
Recalling firm: bioMerieux, Inc.
Product: MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Product code: OUG Medical Device Data System
Reason for recall: Under certain conditions, there is a risk for a false negative result.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0084-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0084-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-08

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)