Z-0719-2022Class I

STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for...

Name: Z-0719-2022 STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for...
Creator: SD Biosensor, Inc.
Published: 2022-01-31
License: https://open.fda.gov/license/

SD Biosensor, Inc. / initiated 2022-01-31 / Open, Classified

FDA source

SD Biosensor, Inc. began a recall of STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2... on 2022-01-31. FDA classified it as Class I and gives the reason as "Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0719-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-01-31
Posted: 2022-03-16
Recalling firm: SD Biosensor, Inc.
Product: STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.
FDA root cause: Under Investigation by firm
Action: On 02/02/2022, SD Biosensor, Inc. a global in-vitro diagnostic company notified U.S Food and Drug Administration (US FDA) that the firm was voluntarily recalling its STANDARD Q COVID-19 Ag Home Test kits due to confirmed reports that the test kits were illegally imported into the U.S. The Home Test kits are not approved or authorized by the US FDA for sale in the U.S. US FDA was informed that the SD Biosensor, Inc. sent a "Cease and Desist Letter Related to STANDARD Q COVID-19 Ag Test in the USA" demanding that the distributor take immediate action to cease and desist from all further sale or activities related to the product for use in the USA. For questions/assistance: U.S. Contact - Tel: +1-714-202-5789 or email [email protected] Korea Contact - Tel: 070-4498-0742
Quantity in commerce: ~400,000 kits
Distribution: U.S. Nationwide Distribution
Product codes and lots: REF No. Q-NCOV-03G Catalog No.: 09COV130 Lot Number: 59628J1T1 (Potentially 59628J1T1/2)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0719-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0719-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-15

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)