INNOVA MEDICAL GROUP, INC. Recall 87682
Description: COVID-19 Self-Test Kit *** INNOVA *** 3T
INNOVA MEDICAL GROUP, INC. Recall 87682 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1539-2021 |
| Event ID | 87682 |
| Event Description | COVID-19 Self-Test Kit *** INNOVA *** 3T |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 402 boxes (=1,206 tests) |
| Recall Reason | Due to distributing test kits to customers who were not part of a clinical investigation. |
| Device Classification | 20210616 |
| Device Code Info | Catalog Number: 3T Lot Numbers: U2102003 X2012310 |
| Center Classification Date | 20210610 |
| Recall Initiation Date | 20210409 |
| Recalling Firm | INNOVA MEDICAL GROUP, INC. |
| Initial Notification | Letter |
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