🔍 RecallPedia

For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309

Class I - Dangerous
🏥 Medical Devices Recalled: April 9, 2021 INNOVA MEDICAL GROUP Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog Number: 25T REF: Bt1309 Lot Numbers: U2101750 U2101751 X2006004 X2008001 X2008010 X2009002 X2009004 X2009013 X2009016 X2010004 X2010010 X2011005 X2011006 X2011007 X2011008 X2011009 X2011012 X2011013 X2011015 X2011016 X2011017 X2011025 X2011051 X2011052 X2012001 X2012002 X2012004 X2012005 X2012008 X2101002 X2101004 X2101014 X2101031 X2101038
  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:
INNOVA MEDICAL GROUP, INC.
Reason for Recall:
Due to distributing test kits to customers who were not part of a clinical investigation.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309

Product Codes/Lot Numbers:

Catalog Number: 25T REF: Bt1309 Lot Numbers: U2101750 U2101751 X2006004 X2008001 X2008010 X2009002 X2009004 X2009013 X2009016 X2010004 X2010010 X2011005 X2011006 X2011007 X2011008 X2011009 X2011012 X2011013 X2011015 X2011016 X2011017 X2011025 X2011051 X2011052 X2012001 X2012002 X2012004 X2012005 X2012008 X2101002 X2101004 X2101014 X2101031 X2101038

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1538-2021

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