San Diego, CA, United States
CUE HEALTH INC recalls
1 recall recorded since 2018, most recently on 24 May 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 May 2024
- Reason
- Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
- Distribution
- U.S. Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0091-2025
- Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.