Class II

Medical Device Recall: Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)

CUE HEALTH INC · May 24, 2024

Reason for Recall

Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.

Distribution

U.S. Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

56 Lots (248,109 total kits)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0091-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

CUE HEALTH INC Medical Device Recall: Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC) | SafeCheck