FDA-Device2021-06-16Class I
COVID-19 Self-Test Kit *** INNOVA *** 3T
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
402 boxes (=1,206 tests)
Manufactured in
800 E Colorado Blvd Ste 200, N/A, Pasadena, CA, United States
Products
COVID-19 Self-Test Kit *** INNOVA *** 3T
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1539-2021Don't want to check this manually?
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