Reported Jun 16, 2021 · Ongoing
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF…
Innova Medical Group, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: INNOVA MEDICAL GROUP, INC. · 800 E Colorado Blvd Ste 200 · Pasadena, CA · 91101-5401
Is this the product you have?
- For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
- Lot codes and dates
- Catalog Number25T
- REFBt1309
- Lot Numbers
U2101750U2101751X2006004X2008001X2008010X2009002X2009004X2009013X2009016X2010004X2010010X2011005X2011006X2011007X2011008X2011009X2011012X2011013X2011015X2011016X2011017X2011025X2011051X2011052X2012001X2012002X2012004X2012005X2012008X2101002X2101004X2101014X2101031X2101038
- Amount recalled
- 1,945 boxes (=48,625 individual tests)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
Due to distributing test kits to customers who were not part of a clinical investigation.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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