FDA-Device2024-10-23Class II
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
CUE HEALTH INC
Hazard
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
Sold states
U.S. Nationwide distribution.
Affected count
56 Lots (248,109 total kits)
Manufactured in
4980 Carroll Canyon Rd Ste 100, San Diego, CA, United States
Products
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0091-2025Don't want to check this manually?
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