FDA recall Z-0719-2022

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 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.

Distribution

U.S. Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2022-01-31

Report date

2022-03-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Suwon, N/A, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0719-2022