INNOVA MEDICAL GROUP, INC.: Medical Device Recall in 2021 - (Recall #: Z-1539-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

COVID-19 Self-Test Kit *** INNOVA *** 3T

Product Classification:

Class I

Date Initiated: April 9, 2021

Date Posted: June 16, 2021

Recall Number: Z-1539-2021

Event ID: 87682

Reason for Recall:

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

Status: Ongoing

Product Quantity: 402 boxes (=1,206 tests)

Code Information:

Catalog Number: 3T Lot Numbers: U2102003 X2012310

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.

Voluntary or Mandated:

Voluntary: Firm initiated