Shenzhen, N/A, China
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD recalls
1 recall recorded since 2018, most recently on 26 June 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 June 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3307-2024, Z-3306-2024, Z-3308-2024
- DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
- DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
- DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.