FDA recall Z-0084-2022

Product

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

Reason for recall

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

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.

Key facts

Status

Terminated

Initiation date

2021-09-02

Report date

2021-10-20

Termination date

2026-03-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

La Balme les Grottes, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0084-2022