CLASS II ONGOING Device recall · Reported 9 Oct 2024 · FDA Enforcement Report
Dvot Sars-CoV-2 & Rsv &MP &Adv & FIu A/B Antigen Combo Test Kit recalled
Feng Chun Yuan Medical Equipment (Shenzhen) is recalling Dvot Sars-CoV-2 & Rsv &MP &Adv & FIu A/B Antigen Combo Test Kit. The recall was initiated on 26 Jun 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3308-2024
- FDA event ID
- 95288
- Recalling firm
- Feng Chun Yuan Medical Equipment (Shenzhen), Shenzhen, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jun 2024
- FDA classified
- 27 Sep 2024
- Reported
- 9 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Jun 2024 | Recall initiated by company | |
| 27 Sep 2024 | Classified by FDA | +93 days |
| 9 Oct 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Product as listed by the FDA
DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
Where it was distributed
International distribution to the countries of China and Hong Kong.
Questions about this recall
Why was it recalled?
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Which lots are affected?
All lots in the United States
Where was it sold?
International distribution to the countries of China and Hong Kong.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 95288This product is part of a recall event; the main page for the event is Dvot Sars-Cov-2 &Influenza A+B Antigen Combo Test Kit recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dvot Sars-Cov-2 &Influenza A+B Antigen Combo Test Kit recalled | Feng Chun Yuan Medical Equipment (Shenzhen) | Other | N/A | |
| CLASS II | Dvot Sars-CoV-2 Antigen Test Kit recalled by Feng Chun Yuan Medical | Feng Chun Yuan Medical Equipment (Shenzhen) | Other | N/A |
More recalls from Feng Chun Yuan Medical Equipment (Shenzhen)
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Dvot Sars-CoV-2 Antigen Test Kit recalled by Feng Chun Yuan Medical | Feng Chun Yuan Medical Equipment (Shenzhen) | Other | N/A |
| Device | CLASS II | Dvot Sars-Cov-2 &Influenza A+B Antigen Combo Test Kit recalled | Feng Chun Yuan Medical Equipment (Shenzhen) | Other | N/A |
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