Recall Z-1539-2021 ยท QKP Coronavirus Antigen Detection Test System.
INNOVA MEDICAL GROUP, INC.
COVID-19 Self-Test Kit *** INNOVA *** 3T
| Date | Apr 9, 2021 |
| Status | Open, Classified |
| Reason | Due to distributing test kits to customers who were not part of a clinical investigation. |
| Root cause | No Marketing Application |
| Action | On or about 04/26/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification via email to its customers informing them that it is recalling products that were distributed outside of a clinical investigation and that the affected products are for investigational use only. The performance characteristics have not been establish and the tests should not be used to screen or diagnose COVID-19. The negative results obtained on the tests are not indicator of the status of SARS-CoV-2 infection. Customers are instructed to: -Check their inventory to see if they have in their possession th |
| Quantity | 402 boxes (=1,206 tests) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.