FDA Medical devices recall ·
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01 recall
- Recall number
- Z-3307-2024
- Date
- (initiated June 26, 2024)
- Company / brand
- Feng Chun Yuan Medical Equipment (Shenzhen)CO.,Ltd
No. 1304 Science And Technology Innovation Park, Shajing Dahong, Shenzhen, N/A, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 120,000 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
Why was it recalled?
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All lots in the United States
Distribution
International distribution to the countries of China and Hong Kong.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3307-2024. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.