FDAClass IIOctober 9, 2024

DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit recall

DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01

Why was DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots in the United States

Product
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
Recalling firm
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Quantity
120,000 kits
Distribution
International distribution to the countries of China and Hong Kong.
Recall date
October 9, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls