Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Reported: October 23, 2024 Initiated: May 24, 2024 #Z-0091-2025
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.
Details
- Recalling Firm
- CUE HEALTH INC
- Units Affected
- 56 Lots (248,109 total kits)
- Distribution
- U.S. Nationwide distribution.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC). Recalled by CUE HEALTH INC. Units affected: 56 Lots (248,109 total kits).
Why was this product recalled? ▼
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 23, 2024. Severity: Moderate. Recall number: Z-0091-2025.
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