FDA Devices Critical Class I Ongoing

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

Reported: June 16, 2021 Initiated: April 9, 2021 #Z-1538-2021

Product Description

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

Reason for Recall

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

Details

Recalling Firm: INNOVA MEDICAL GROUP, INC.
Units Affected: 1,945 boxes (=48,625 individual tests)
Distribution: 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.
Location: Pasadena, CA

Frequently Asked Questions

What product was recalled? ▼

For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309. Recalled by INNOVA MEDICAL GROUP, INC.. Units affected: 1,945 boxes (=48,625 individual tests).

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 16, 2021. Severity: Critical. Recall number: Z-1538-2021.