FDA-Device2023-05-31Class I
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
SD Biosensor, Inc.
Hazard
The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
Sold states
US Nationwide.
Affected count
2,712,767 kits
Manufactured in
1556 Beon-Gil, Yeongtong, C4th & 5th Floor Digital Empire Bldg, 16, Deogyeong-Daero, Suwon, N/A, Korea (the Republic of)
Products
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1594-2023Don't want to check this manually?
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