CLASS II Device recall · Reported 16 Oct 2019 · FDA Enforcement Report
V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage recalled
Vital Scientific N.V is recalling V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An, distributed nationwide in the US. The recall was initiated on 7 Sep 2018 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-0038-2020
- FDA event ID
- 83648
- Recalling firm
- Vital Scientific N.V, Dieren, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Sep 2018
- FDA classified
- 4 Oct 2019
- Reported
- 16 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Patient Monitors
Timeline
| 7 Sep 2018 | Recall initiated by company | |
| 4 Oct 2019 | Classified by FDA | +392 days |
| 16 Oct 2019 | 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 action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned and the reagent storage conditions may fall out of specification.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
V-Twin, Catalog # 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 Nationwide distribution including the state of New York.
Questions about this recall
Why was it recalled?
The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned and the reagent storage conditions may fall out of specification.
Which lots are affected?
The following serial numbers: 14-3301-14-3344; 15-3301-15-3326; 16-3301 -16-3353; 17-3301 -17-3346; 18-3301-18-3323
Where was it sold?
US Nationwide distribution including 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 |