CLASS II ONGOING Device recall · Reported 2 Oct 2019 · FDA Enforcement Report
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage recalled
Vital Scientific N.V is recalling V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An, distributed in New York. The recall was initiated on 18 Jan 2016 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-2558-2019
- FDA event ID
- 83607
- Recalling firm
- Vital Scientific N.V, Dieren
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jan 2016
- FDA classified
- 23 Sep 2019
- Reported
- 2 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
- Patient Monitors
Timeline
| 18 Jan 2016 | Recall initiated by company | |
| 23 Sep 2019 | Classified by FDA | +1344 days |
| 2 Oct 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Instrument stopped working due to a software lockup, 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
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Where it was distributed
US in the state of New York.
Questions about this recall
Why was it recalled?
Instrument stopped working due to a software lockup, and no patient results are produced.
Which lots are affected?
Serial #s: 13-3341 and 13-3344
Where was it sold?
US in the state of New York.
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.
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 | Other | NY |
| Device | CLASS II | Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage recalled | Vital Scientific N.V | Device Malfunction | Nationwide |
| 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 |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |