FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD: Medical Device Recall in 2024 - (Recall #: Z-3308-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 26, 2024

Date Posted: October 9, 2024

Recall Number: Z-3308-2024

Event ID: 95288

Reason for Recall:

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

Status: Ongoing

Product Quantity: 50,000 kits

Code Information:

All lots in the United States

Distribution Pattern:

International distribution to the countries of China and Hong Kong.

Voluntary or Mandated:

Voluntary: Firm initiated