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INNOVA MEDICAL GROUP, INC. Recall 87682

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

INNOVA MEDICAL GROUP, INC. Recall 87682 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1539-2021
Event ID87682
Event DescriptionCOVID-19 Self-Test Kit *** INNOVA *** 3T
Product TypeDevices
DistributionWorldwide 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.
Quantity402 boxes (=1,206 tests)
Recall ReasonDue to distributing test kits to customers who were not part of a clinical investigation.
Device Classification20210616
Device Code InfoCatalog Number: 3T Lot Numbers: U2102003 X2012310
Center Classification Date20210610
Recall Initiation Date20210409
Recalling FirmINNOVA MEDICAL GROUP, INC.
Initial Notification Letter
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