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
- Recall Number
- Z-0719-2022
- Event Number
- 89527
- Firm
- SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire
- FEI Number
- 3012133212
- Product Code
- QKP
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- January 31, 2022
- Address
- Bldg 16, Deogyeong-Daero Suwon Korea (the Republic, of)
Description
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.
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.
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
U.S. Nationwide Distribution
~400,000 kits