CUE HEALTH INC: Device Recall
Recall #Z-0091-2025 · 05/24/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0091-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- CUE HEALTH INC
- Status
- Ongoing
- Date Initiated
- 05/24/2024
- Location
- San Diego, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56 Lots (248,109 total kits)
Reason for Recall
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
Product Description
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Distribution Pattern
U.S. Nationwide distribution.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.