Z-3308-2024Class II

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

Name: Z-3308-2024 DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
Creator: Feng Chun Yuan Medical Equipment (Shenzhen)co.,ltd
Published: 2024-06-26
License: https://open.fda.gov/license/

Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd. / initiated 2024-06-26 / Open, Classified

FDA source

FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD began a recall of DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01 on 2024-06-26. FDA classified it as Class II and gives the reason as "The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3308-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-26
Posted: 2024-09-27
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
Product code: QYT Over-The-Counter Covid-19 Antigen Test
Reason for recall: The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
FDA 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 [email protected]. Your prompt attention and adherence to these directives are greatly appreciated as we work together to uphold regulatory compliance and ethical business practices.
Quantity in commerce: 50,000 kits
Distribution: International distribution to the countries of China and Hong Kong.
Product codes and lots: All lots in the United States

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3308-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3306-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-09	2024-09-27
Z-3307-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-09	2024-09-27
Z-3308-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-09	2024-09-27

Product code QYT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)