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INNOVA MEDICAL GROUP, INC. recalls COVID-19 Self-Test Kit *** INNOVA *** 7T
Recalled June 16, 2021 · FDA recall Z-1537-2021 · INNOVA MEDICAL GROUP
Hazard
Due to distributing test kits to customers who were not part of a clinical investigation. · FDA Class I
Units
370 boxes (=2,590 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
COVID-19 Self-Test Kit *** INNOVA *** 7T
Manufacturer(s)
INNOVA MEDICAL GROUP, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →