Dieren, N/A, Netherlands
Vital Scientific N.V. recalls
4 recalls recorded since 2018, most recently on 15 November 2018. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 15 November 2018
- Reason
- During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.
- Distribution
- NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0547-2020
- V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Terminated Class II Medical devices
- Recall started
- 7 September 2018
- Terminated
- 29 June 2022
- Reason
- 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.
- Distribution
- US Nationwide distribution including the state of New York.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0038-2020
- 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 mea
Ongoing Class II Medical devices
- Recall started
- 18 January 2016
- Reason
- Instrument stopped working due to a software lockup, and no patient results are produced.
- Distribution
- US in the state of New York.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2558-2019
- 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 mea
Terminated Class II Medical devices
- Recall started
- 10 January 2012
- Terminated
- 19 April 2024
- Reason
- The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- Distribution
- US Nationwide in the states of NY, and UT
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0154-2020, Z-0158-2020, Z-0156-2020, Z-0157-2020, Z-0155-2020
- Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
- Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
- V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
- Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
- Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.