FDA-Device2021-11-17Class I
Ellume COVID-19 Home Test
ELLUME LTD
Hazard
Due to a higher rate of false positive test results.
Sold states
U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
Affected count
427,994 kits
Manufactured in
57 Didsbury St, N/A, East Brisbane, N/A, Australia
Products
Ellume COVID-19 Home Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0183-2022Don't want to check this manually?
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