Home / Recalls / Medical Devices
INNOVA MEDICAL GROUP, INC. recalls For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT
Recalled June 16, 2021 · FDA recall Z-1538-2021 · INNOVA MEDICAL GROUP
Hazard
Due to distributing test kits to customers who were not part of a clinical investigation. · FDA Class I
Units
1,945 boxes (=48,625 individual tests)
Sold at
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.
Description
Due to distributing test kits to customers who were not part of a clinical investigation.
Product
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
Manufacturer(s)
INNOVA MEDICAL GROUP, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →