CUE Health Inc.
FDA adverse event reports naming CUE Health Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: CUE HEALTH INC..
- Total reports
- 1,837
- Deaths
- 0
- Injuries
- 2
- Malfunctions
- 1,835
Reports per year
57022
1,07623
19124
Source: FDA adverse event reports by year received, 2022–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2024-10-15Open, ClassifiedNo Marketing Application
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
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