Z-1538-2021Class I

For In Vitro Diagnostic Use Only * 25T 888 SARS-CoV-2 Antigen * SARS-CoV-2 Antigen Rapid Qualitative Test...

Name: Z-1538-2021 For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test...
Creator: Innova Medical Group, Inc.
Published: 2021-04-09
License: https://open.fda.gov/license/

Innova Medical Group, Inc. / initiated 2021-04-09 / Open, Classified

FDA source

INNOVA MEDICAL GROUP, INC. began a recall of For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309 on 2021-04-09. FDA classified it as Class I and gives the reason as "Due to distributing test kits to customers who were not part of a clinical investigation". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1538-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-04-09
Posted: 2021-06-10
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
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: Due to distributing test kits to customers who were not part of a clinical investigation.
FDA 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 [email protected] or 747-494-0852.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1538-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1537-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-06-16	2021-06-10
Z-1538-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-06-16	2021-06-10
Z-1539-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-06-16	2021-06-10

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)