Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066
  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:
Trinity Biotech USA
Reason for Recall:
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.

Product Codes/Lot Numbers:

Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2292-2025