FDA recall Z-1538-2021

INNOVA MEDICAL GROUP, INC. · Class I · device

Product

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.

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.

Key facts

Status: Ongoing
Initiation date: 2021-04-09
Report date: 2021-06-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pasadena, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1538-2021