Medical device recalls Moderate risk

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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