Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0719-2022

January 31, 2022

Class I

Product summary

Firm
SD Biosensor, Inc.
Event
Event 89527
Status
Ongoing
Classification
Class I
Quantity
~400,000 kits
Official record key
device-enforcement:Z-0719-2022

Official wording

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.

Code information: REF No. Q-NCOV-03G Catalog No.: 09COV130 Lot Number: 59628J1T1 (Potentially 59628J1T1/2)

Distribution pattern: U.S. Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.