Recall Z-3307-2024— FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Class II · Ongoing
Class II FDA medical device recall by FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD, initiated 2024-06-26. FDA's recall record names no specific 510(k) clearance for this event. Product: DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01. Reason: The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States..
- Recalling firm
- FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-26
- Firm location
- Shenzhen, N/A, China
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.