FDA Medical Device Recalls (openFDA)
INNOVA MEDICAL GROUP, INC.: For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
- Recall number
- Z-1538-2021
- Recalling firm
- INNOVA MEDICAL GROUP, INC.
- Product
- For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
- Status
- Open, Classified
- Initiated
- 2021-04-09
- Posted
- not on file
- Terminated
- not on file
- 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 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.
- Quantity
- 1,945 boxes (=48,625 individual 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.
- Lot, serial or model codes
- Catalog Number: 25T REF: Bt1309 Lot Numbers: U2101750 U2101751 X2006004 X2008001 X2008010 X2009002 X2009004 X2009013 X2009016 X2010004 X2010010 X2011005 X2011006 X2011007 X2011008 X2011009 X2011012 X2011013 X2011015 X2011016 X2011017 X2011025 X2011051 X2011052 X2012001 X2012002 X2012004 X2012005 X2012008 X2101002 X2101004 X2101014 X2101031 X2101038
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3018074194
- Firm city
- Pasadena
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28