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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