The Recall Desk
ModerateFDA (Devices)·Z-3307-2024·Announced 2024-10-09

DVOT SARS-CoV-2 and Influenza Antigen Test Kits lack FDA authorization

The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) has not obtained FDA authorization for sale in the United States. All lots distributed in the U.S. are subject to recall.

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 an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is regulatory non-compliance (lack of authorization) rather than a confirmed safety defect, consistent with voluntary precautionary recalls.

Plain-English summary

The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) is manufactured by FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD and has not obtained the necessary FDA authorization to be sold in the United States. Approximately 120,000 kits were distributed.

All lots of this product in the United States are subject to this recall. The product was marketed under the DVOT brand but lacks required regulatory approval for sale in the U.S. market.

The recalled product

Product
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
Manufacturer
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Category
Medical Device — Diagnostic Test Kit
Hazard
  • unauthorized-medical-device
  • unverified-diagnostic

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.

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