Diagnostic Kit SARS-cCo V Antigen Rapid Test

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None
  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:
USA Medical, LLC
Reason for Recall:
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Diagnostic Kit SARS-cCo V Antigen Rapid Test

Product Codes/Lot Numbers:

Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1050-2022