FDA-Device2021-06-16Class I
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
INNOVA MEDICAL GROUP, INC.
Hazard
Due to distributing test kits to customers who were not part of a clinical investigation.
Sold states
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.
Affected count
1,945 boxes (=48,625 individual tests)
Manufactured in
800 E Colorado Blvd Ste 200, N/A, Pasadena, CA, United States
Products
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1538-2021Don't want to check this manually?
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