Reported Mar 23, 2022 · Ongoing

STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the…

SD Biosensor, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SD Biosensor, Inc. · 1556 Beon-Gil, Yeongtong · Suwon, N/A · N/A

Is this the product you have?

  • 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.
Lot codes and dates
  • REF No. Q-NCOV-03G Catalog No.: 09COV130
  • Lot Number59628J1T1 (Potentially 59628J1T1/2)
Amount recalled
~400,000 kits

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.