ELLUME LTD recalls Ellume COVID-19 Home Test

Recall date

October 1, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0183-2022

FDA classification

Class I

Brand / firm

ELLUME LTD

Sold / distributed

U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided

Why it was recalled

Due to a higher rate of false positive test results.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Ellume COVID-19 Home Test