FDA recall Z-1539-2021

Product

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

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-1539-2021