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Recall Observatory FDA recall evidence

Device product

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

Z-1537-2021

April 09, 2021

Class I

Product summary

Firm
INNOVA MEDICAL GROUP, INC.
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

    reason.no_named_rule · v1.0.0

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