The Recall Desk
ModerateFDA (Devices)·Z-3306-2024·Announced 2024-10-09

DVOT SARS-CoV-2 Antigen Test Kit Recalled for Lack of FDA Authorization

The DVOT SARS-CoV-2 Antigen Test Kit (Model FCY-AGT-01) manufactured by Feng Chun Yuan Medical Equipment has been recalled from the U.S. market because it was not authorized for sale in the United States.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is classified as an FDA Class II recall with no reported illnesses or injuries. The hazard is the lack of FDA authorization, not a specific documented safety defect. Per the severity rubric, Class II recalls without reported harm are scored as Moderate.

Plain-English summary

The DVOT SARS-CoV-2 Antigen Test Kit, Model FCY-AGT-01, manufactured by Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd, has been recalled from the United States market. This recall involves approximately 150,000 test kits.

The product is subject to this recall because it was not authorized for sale in the United States. The manufacturer did not obtain the necessary FDA authorization to legally distribute this test kit in the U.S. market.

Persons in possession of this test kit should not use it for COVID-19 testing, as the product has not undergone FDA review and approval for safety and effectiveness.

The recalled product

Product
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
Manufacturer
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Category
Medical Device — COVID-19 Diagnostic Test
Hazard
  • unauthorized-device

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots in the United States

Distribution

Distribution scope not specified by the agency.

Related recalls

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