Z-1539-2021Class I

COVID-19 Self-Test Kit * INNOVA * 3T

Name: Z-1539-2021 COVID-19 Self-Test Kit *** INNOVA *** 3T
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 COVID-19 Self-Test Kit *** INNOVA *** 3T 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-1539-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-04-09
Posted: 2021-06-10
Recalling firm: Innova Medical Group, Inc.
Product: COVID-19 Self-Test Kit *** INNOVA *** 3T
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: 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.
Product codes and lots: Catalog Number: 3T Lot Numbers: U2102003 X2012310

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1539-2021
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)