Device product
COVID-19 Self-Test Kit *** INNOVA *** 7T
Z-1537-2021
Product summary
- Event
- Event 87682
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 370 boxes (=2,590 individual tests)
- Official record key
device-enforcement:Z-1537-2021
Official wording
Reason: Due to distributing test kits to customers who were not part of a clinical investigation.
Code information: Catalog Number: 7T Lot Numbers: U2101748 U2102001 U2102002 X2012711 X2103792
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.