Recall Z-0719-2022— SD Biosensor, Inc.
Class I · Ongoing
Class I FDA medical device recall by SD Biosensor, Inc., initiated 2022-01-31. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- SD Biosensor, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-01-31
- Firm location
- Suwon, N/A, Korea (the Republic of)
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.