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 B…

Recall date

April 9, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1538-2021

FDA classification

Class I

Brand / firm

INNOVA MEDICAL GROUP, INC.

Sold / distributed

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.

Why it was recalled

Due to distributing test kits to customers who were not part of a clinical investigation.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309