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.
Vital Scientific N.V.
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
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.
Instrument stopped working due to a software lockup, and no patient results are produced.