Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Recalled by CUE HEALTH INC Due to Due to modified test kits being marketed and...

Date: May 24, 2024
Company: CUE HEALTH INC
Status: Ongoing
Source: FDA (Device)

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 CUE HEALTH INC directly.

Affected Products

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

Quantity: 56 Lots (248,109 total kits)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CUE HEALTH INC

CUE HEALTH INC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report