🔍 RecallPedia

Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023

Class I - Dangerous
🏥 Medical Devices Recalled: October 30, 2020 Luminex Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    030420023A, 031720023A, 032520023A, 040820023B, 041520023B, 042220023B, 042820023A, 050120023A, 050620023B, 050820023B, 052720023A, 052820023A, 060420023A, 060620023A, 061120023A, 061820023A, 062520023A, 062720023A, 070220023A, 070920023A, 071420023A, 071720023A, 072820023A, 080420023A, and 090920023A
  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:
Luminex Corporation
Reason for Recall:
Potential for a false-negative result.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023

Product Codes/Lot Numbers:

030420023A, 031720023A, 032520023A, 040820023B, 041520023B, 042220023B, 042820023A, 050120023A, 050620023B, 050820023B, 052720023A, 052820023A, 060420023A, 060620023A, 061120023A, 061820023A, 062520023A, 062720023A, 070220023A, 070920023A, 071420023A, 071720023A, 072820023A, 080420023A, and 090920023A

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2009-2021

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