Recall Z-0091-2025— CUE HEALTH INC
Class II · Ongoing
Class II FDA medical device recall by CUE HEALTH INC, initiated 2024-05-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC). Reason: Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization..
- Recalling firm
- CUE HEALTH INC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-24
- Firm location
- San Diego, CA, United States
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)
Reason for recall
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
Data sourced from openFDA. This site is unofficial and independent of the FDA.