Recall Z-0719-2022 ยท QKP Coronavirus Antigen Detection Test System.
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.
| Date | Jan 31, 2022 |
| Status | Open, Classified |
| 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 o |
| Quantity | ~400,000 kits |
| Distribution | U.S. Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.