uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    version 1.1
  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:
Roche Molecular Systems, Inc.
Reason for Recall:
When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001

Product Codes/Lot Numbers:

version 1.1

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0877-2021

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