Z-2225-2021Class II

MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission...

Name: Z-2225-2021 MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission...
Creator: BioMerieux SA
Published: 2021-06-22
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2021-06-22 / Terminated / root cause: software

FDA source

BioMerieux SA began a recall of MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying... on 2021-06-22. FDA classified it as Class II and gives the reason as "Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature". 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-2225-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-22
Posted: 2021-08-06
Terminated: 2023-02-06
Recalling firm: bioMerieux, Inc.
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.
Product code: N/A
Reason for recall: Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Root cause tag: software
FDA 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 in commerce: 248 systems
Distribution: Distribution in the U.S. was nationwide. There was also military and government distribution.
Product codes and lots: MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2225-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2225-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-06

Product code N/A

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)