DVOT Rapid Antigen Test Kits Recalled for Lack of FDA Authorization
DVOT antigen test kits lack FDA authorization for US sale. Approximately 50,000 unauthorized kits were distributed. Users should discontinue use immediately due to unvalidated safety and accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an unauthorized medical diagnostic device. No adverse events have been reported; however, the lack of FDA authorization means the test kit's safety and accuracy are unvalidated. The use of unvalidated diagnostic tests creates a risk-of-harm situation where false results could lead to incorrect medical decisions.
Plain-English summary
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD is recalling approximately 50,000 DVOT SARS-CoV-2 & RSV & MP & ADV & FLU A/B Antigen Combo Test Kits (Model ACT01) because the product has not obtained the necessary authorization to be sold in the United States.
FDA authorization for medical diagnostic devices ensures they meet established standards for safety and accuracy. Use of an unauthorized test kit means the reliability of results cannot be assured, potentially leading to false positive or false negative results that could result in incorrect health decisions.
All lots of this product distributed in the United States are affected by this recall.
Consumers who have obtained this product should discontinue use immediately and dispose of the kits properly. Healthcare providers who may have stocked these unauthorized test kits should remove them from inventory and cease distribution.
The recalled product
- Product
- DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
- Category
- Medical Device — Diagnostic Test
- Affected units
- 50,000
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.
Part of a larger recall action
This product is one of 3 recalled by FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
See all →- ModerateDVOT SARS-CoV-2 Antigen Test Kit Recalled for Lack of FDA Authorization
FDA (Devices) · 2024-10-09
- ModerateDVOT SARS-CoV-2 and Influenza Antigen Test Kits lack FDA authorization
FDA (Devices) · 2024-10-09
Same hazard · unauthorized medical device
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FDA (Devices) · 2022-03-23
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FDA (Devices) · 2022-03-16
- SevereCOVID-19 Rapid Antigen Test Kit Distributed Without FDA Approval
FDA (Devices) · 2022-02-09
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