# FDA recall Z-3307-2024

> **FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD** · Class II · device recall initiated 2024-06-26.

## Product

DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01

## Reason for recall

The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.

## Distribution

International distribution to the countries of China and Hong Kong.

## Key facts

- **Recall number:** Z-3307-2024
- **Recalling firm:** FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-26
- **Report date:** 2024-10-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Shenzhen, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3307-2024

## Citation

> AI Analytics. FDA recall Z-3307-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-3307-2024. Source: US FDA. Licensed CC0.

---

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