Device product
COVID-19 Self-Test Kit *** INNOVA *** 3T
Z-1539-2021
Product summary
- Event
- Event 87682
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 402 boxes (=1,206 tests)
- Official record key
device-enforcement:Z-1539-2021
Official wording
Reason: Due to distributing test kits to customers who were not part of a clinical investigation.
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.
Derived failure modes
-
Unknown
Due to distributing test kits to customers who were not part of a clinical investigation.