FDA-Device2021-10-20Class II
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
BioMerieux SA
Hazard
Under certain conditions, there is a risk for a false negative result.
Sold states
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.
Affected count
542 units
Manufactured in
3 route de Port Michaud, N/A, La Balme les Grottes, N/A, France
Products
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0084-2022Don't want to check this manually?
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