Home / Recalls / INNOVA MEDICAL GROUP, INC. / Z-1537-2021

Z-1537-2021 Class I Ongoing

Recalled by INNOVA MEDICAL GROUP, INC. — Pasadena, CA

Recall Details

Product Type
Devices
Report Date
June 16, 2021
Initiation Date
April 9, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
370 boxes (=2,590 individual tests)

Product Description

COVID-19 Self-Test Kit *** INNOVA *** 7T

Reason for Recall

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

Distribution Pattern

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.

Code Information

Catalog Number: 7T Lot Numbers: U2101748 U2102001 U2102002 X2012711 X2103792

Other recalls by INNOVA MEDICAL GROUP, INC.

  • Z-1538-2021 Class I — For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 A (April 9, 2021)
  • Z-1539-2021 Class I — COVID-19 Self-Test Kit *** INNOVA *** 3T (April 9, 2021)