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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

INNOVA MEDICAL GROUP, INC.: Due to distributing test kits to customers who were not part of a clinical investigation.

Agency Publication Date: June 10, 2021
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Affected Products

Product: COVID-19 Self-Test Kit *** INNOVA *** 7T

Catalog Number: 7T Lot Numbers: U2101748 U2102001 U2102002 X2012711 X2103792

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

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

Lot Numbers:
Numbers
Product: COVID-19 Self-Test Kit *** INNOVA *** 3T

Catalog Number: 3T Lot Numbers: U2102003 X2012310

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87682
Status: Active
Manufacturer: INNOVA MEDICAL GROUP, INC.
Manufactured In: United States
Units Affected: 3 products (370 boxes (=2,590 individual tests); 1,945 boxes (=48,625 individual tests); 402 boxes (=1,206 tests))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.