Recall Z-0719-2022
SD Biosensor, Inc. · initiated January 31, 2022
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: REF No. Q-NCOV-03G Catalog No.: 09COV130 Lot Number: 59628J1T1 (Potentially 59628J1T1/2)
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-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-0719-2022
- Initiated
- January 31, 2022
- Product code
- QKP – Coronavirus Antigen Detection Test System.
- Quantity
- ~400,000 kits
- Distribution
- U.S. Nationwide Distribution
- Recalling firm
- SD Biosensor, Inc.