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ELLUME LTD recalls Ellume COVID-19 Home Test
Recalled November 17, 2021 · FDA recall Z-0183-2022 · ELLUME
Hazard
Due to a higher rate of false positive test results. · FDA Class I
Units
427,994 kits
Sold at
U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
Description
Due to a higher rate of false positive test results.
Product
Ellume COVID-19 Home Test
Manufacturer(s)
ELLUME LTD
Made in
Australia
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →