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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
BioMerieux SA
Reason for Recall:
Under certain conditions, there is a risk for a false negative result.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
completed

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0084-2022

Related Recalls

Invalid calibration with low calibrator S1 while using the product.

Apr 9, 2018 Diagnostic Equipment View Details β†’