COVID-19 Self-Test Kit *** INNOVA *** 7T
- Company
- Innova Medical Group, Inc.
- Recall Initiated
- April 9, 2021
- Recall Number
- Z-1537-2021
- Quantity
- 370 boxes (=2,590 individual tests)
- Firm Location
- Pasadena, CA
Reason for Recall
Due to distributing test kits to customers who were not part of a clinical investigation.
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.
Lot / Code Info
Catalog Number: 7T Lot Numbers: U2101748 U2102001 U2102002 X2012711 X2103792
Root Cause
No Marketing Application
Action Taken
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 the affected products. -If they have affected products, they are to count the test kits and write the number on the accompanying "MEDICAL DEVICE RECALL RETURN RESPONSE" form and return the form to the Recalling Firm via the provided FedEx envelope. -Destroy (by placing in your household waste) or return the affected products (Customer's choice), but to include the total number of destroyed and returned test on the "MEDICAL DEVICE RECALL RETURN RESPONSE" form. For any questions or assistance, contact Linda Weinreb at Linda.Weinreb@innovamedgroup.com or 747-494-0852.