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Vital Scientific N.V Recalls
8 recalls on record · October 2, 2019 to December 4, 2019 · Medical Devices
December 4, 2019Medical DevicesFDA
Vital Scientific N.V. recalls V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Hazard: 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.
October 23, 2019Medical DevicesFDA
Vital Scientific N.V. recalls Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended f
Hazard: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
October 23, 2019Medical DevicesFDA
Vital Scientific N.V. recalls Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product U
Hazard: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
October 23, 2019Medical DevicesFDA
Vital Scientific N.V. recalls V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical
Hazard: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
October 23, 2019Medical DevicesFDA
Vital Scientific N.V. recalls Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical
Hazard: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
October 23, 2019Medical DevicesFDA
Vital Scientific N.V. recalls Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clin
Hazard: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
October 16, 2019Medical DevicesFDA
Vital Scientific N.V. recalls V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated ch
Hazard: 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.
October 2, 2019Medical DevicesFDA
Vital Scientific N.V. recalls V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated ch
Hazard: Instrument stopped working due to a software lockup, and no patient results are produced.