DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
Reported: October 9, 2024 Initiated: June 26, 2024 #Z-3308-2024
Product Description
DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
Reason for Recall
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Details
- Recalling Firm
- FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
- Units Affected
- 50,000 kits
- Distribution
- International distribution to the countries of China and Hong Kong.
- Location
- Shenzhen, N/A
Frequently Asked Questions
What product was recalled? ▼
DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01. Recalled by FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD. Units affected: 50,000 kits.
Why was this product recalled? ▼
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2024. Severity: Moderate. Recall number: Z-3308-2024.
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