Z-1537-2021 Class I Ongoing
FDA device recall Z-1537-2021 was initiated by INNOVA MEDICAL GROUP, INC. on April 9, 2021 and is designated Class I. Reason for recall: Due to distributing test kits to customers who were not part of a clinical investigation. The recall status is ongoing. Affected quantity: 370 boxes (=2,590 individual tests).
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- April 9, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 370 boxes (=2,590 individual tests)
Product Description
COVID-19 Self-Test Kit *** INNOVA *** 7T
Reason for Recall
Due to distributing test kits to customers who were not part of a clinical investigation.
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.
Code Information
Catalog Number: 7T Lot Numbers: U2101748 U2102001 U2102002 X2012711 X2103792