BioMerieux SA: Medical Device Recall in 2021 - (Recall #: Z-0084-2022)

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

Product Classification:

Class II

Date Initiated: September 2, 2021

Date Posted: October 20, 2021

Recall Number: Z-0084-2022

Event ID: 88658

Reason for Recall:

Under certain conditions, there is a risk for a false negative result.

Status: Terminated

Product Quantity: 542 units

Code Information:

MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated