FDA Medical Device Recalls (openFDA)
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD: DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
- Recall number
- Z-3308-2024
- Recalling firm
- FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
- Product
- DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
- Status
- Open, Classified
- Initiated
- 2024-06-26
- Posted
- 2024-09-27
- Terminated
- not on file
- Reason
- The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
- Root cause
- Unknown/Undetermined by firm
- Action
- A Notification letter dated 6/26/24 was sent to customers: To all esteemed exporters and distributors: It has come to our attention that the "DVOT brand" rapid test kits manufactured by our company have not obtained the necessary authorized from the US FDA (EUA & 510K). Consequently, any attempt to sell these products within the United States is in direct violation of legal regulations and carries significant legal liabilities. In light of this, we wish to formally notify you of the following: 1. The sale or distribution of DVOT brand rapid test kits within the territory of the United States is strictly prohibited. Any party found in contravention will face immediate suspension of their supplies, with severe violators facing potential termination of cooperation. 2. For comprehensive details regarding product recalls or related matters, we urge you to contact our dedicated Quality Manager, Romon at romen@fcy-medical.com. Your prompt attention and adherence to these directives are greatly appreciated as we work together to uphold regulatory compliance and ethical business practices.
- Quantity
- 50,000 kits
- Distribution
- International distribution to the countries of China and Hong Kong.
- Lot, serial or model codes
- All lots in the United States
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QYT
- Firm FEI
- 3016652804
- Firm city
- Shajing Dahong Shenzhen
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28