DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01

FDA device recall Z-3308-2024 · posted 2024-09-27 · Open, Classified

Recall details

Recalling firm

FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD

Reason for recall

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

Action taken

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.

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

QYT

Quantity affected

50,000 kits

Distribution

International distribution to the countries of China and Hong Kong.

Date initiated

2024-06-26

Date posted

2024-09-27

Location

Shajing Dahong Shenzhen, China