Reported Oct 20, 2021 · Terminated

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

BioMerieux SA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BioMerieux SA · 3 route de Port Michaud · La Balme les Grottes, N/A · N/A

Is this the product you have?

  • MYLA Versions
    • 4.7
    • 4.7.1
    • 4.8
    • 4.8.1 and 4.8.2
    • part of the VIRTUO System
Lot codes and dates
    • MYLA Software version 4.7
    • 4.7.1
    • 4.8
    • 4.8.1 and 4.8.2
Amount recalled
542 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 9, 2026 · Data as of Sep 19, 6:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.