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Recall Observatory FDA recall evidence

Device product

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

Z-1538-2021

April 09, 2021

Class I

Product summary

Firm
INNOVA MEDICAL GROUP, INC.
Event
Event 87682
Status
Ongoing
Classification
Class I
Quantity
1,945 boxes (=48,625 individual tests)
Official record key
device-enforcement:Z-1538-2021

Official wording

Reason: Due to distributing test kits to customers who were not part of a clinical investigation.

Code information: 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

Distribution pattern: Worldwide distribution - U.S. Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, India and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to distributing test kits to customers who were not part of a clinical investigation.