FDA Medical Device Recalls (openFDA)
SD Biosensor, Inc.: 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.
- Recall number
- Z-0719-2022
- 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.
- Status
- Open, Classified
- Initiated
- 2022-01-31
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- 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 info@lkconsultinggroup.com Korea Contact - Tel: 070-4498-0742
- Quantity
- ~400,000 kits
- Distribution
- U.S. Nationwide Distribution
- Lot, serial or model codes
- REF No. Q-NCOV-03G Catalog No.: 09COV130 Lot Number: 59628J1T1 (Potentially 59628J1T1/2)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3012133212
- Firm city
- not on file
- Firm state
- not on file
- 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