FDA recall Z-0091-2025

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 for recall

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

Distribution

U.S. Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-05-24

Report date

2024-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0091-2025