CUE HEALTH INC recalls Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (O

Recalled October 23, 2024 · FDA recall Z-0091-2025 · CUE HEALTH

Hazard

Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization. · FDA Class II

Units

56 Lots (248,109 total kits)

Sold at

U.S. Nationwide distribution.

Description

Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.

Product

Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)

Manufacturer(s)

CUE HEALTH INC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →