CUE HEALTH INC recalls Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
- Recall date
- May 24, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0091-2025
- FDA classification
- Class II
- Brand / firm
- CUE HEALTH INC
- Sold / distributed
- U.S. Nationwide distribution.
Why it was recalled
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
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