# FDA recall Z-0091-2025

> **CUE HEALTH INC** · Class II · device recall initiated 2024-05-24.

## 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

- **Recall number:** Z-0091-2025
- **Recalling firm:** CUE HEALTH INC
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0091-2025. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-0091-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*