Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Ellume COVID-19 Home Test Recalled by ELLUME LTD Due to Due to a higher rate of false positive...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ELLUME LTD directly.
Affected Products
Ellume COVID-19 Home Test
Quantity: 427,994 kits
Why Was This Recalled?
Due to a higher rate of false positive test results.
Where Was This Sold?
This product was distributed to 6 states: MN, NY, PA, RI, UT, WA
About ELLUME LTD
ELLUME LTD has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report