BioMerieux SA: Medical Device Recall in 2021 - (Recall #: Z-2225-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 22, 2021

Date Posted: August 18, 2021

Recall Number: Z-2225-2021

Event ID: 87985

Reason for Recall:

Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.

Status: Terminated

Product Quantity: 248 systems

Code Information:

MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975.

Distribution Pattern:

Distribution in the U.S. was nationwide. There was also military and government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated