DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
Summary
The FDA issued a Class II for DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number AC by FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD. Reason: The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States..
Details
Source
Device Recall
External ID
Z-3308-2024
Action Date
2024-10-09
Status
Ongoing
Category
device
Product Description
DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
Lot/Code Info: All lots in the United States
Quantity Affected: 50,000 kits
Reason for Recall
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Distribution
International distribution to the countries of China and Hong Kong.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-26
Company
Shenzhen, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 218 device recalls issued in the same week, part of 403 device-related FDA actions this month.
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD have FDA actions?
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3308-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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