CLASS II Device recall · Reported 23 Oct 2019 · FDA Enforcement Report
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage recalled
Vital Scientific N.V is recalling Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage, distributed nationwide in the US. The recall was initiated on 10 Jan 2012 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-0155-2020
- FDA event ID
- 83582
- Recalling firm
- Vital Scientific N.V, Dieren, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jan 2012
- FDA classified
- 16 Oct 2019
- Reported
- 23 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Jan 2012 | Recall initiated by company | |
| 16 Oct 2019 | Classified by FDA | +2836 days |
| 23 Oct 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
Where it was distributed
US Nationwide in the states of NY, and UT
Questions about this recall
Is Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage recalled?
Yes. Vital Scientific N.V recalled Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage on 10 Jan 2012. The recall is Class II and its status is Terminated. Recall number Z-0155-2020.
Why was it recalled?
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Which lots are affected?
serial numbers: 10-4582 till 10-4584; 10-4586 till 10-4594; 11-2309; 11-2320 t through 11-2328; 11-2330 through-2334; 11-2336 through 11-2375; 11-2383; 11-2384; 11-2388; 11-2395; 12-2314; 12-2315; 12-2324 12-2325.
Where was it sold?
US Nationwide in the states of NY, and UT
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Vital Scientific N.V
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD recalled | Vital Scientific N.V | Lead & Heavy Metals | NY |
| Device | CLASS II | Selectra ProM Analyzer recalled by Vital Scientific N.V | Vital Scientific N.V | Device Malfunction | Nationwide |
| Device | CLASS II | V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage recalled | Vital Scientific N.V | Device Malfunction | Nationwide |
| Device | CLASS II | Selectra ProS Analyzer recalled by Vital Scientific N.V | Vital Scientific N.V | Device Malfunction | Nationwide |
| Device | CLASS II | Viva - JR recalled by Vital Scientific N.V | Vital Scientific N.V | Device Malfunction | Nationwide |
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