The investigation determined that lower and higher than expected results were obtained from quality control fluids using 3 different lots of vitros phenytoin (phyt) micro slides on a vitros 5600 integrated system.The assignable cause of the event is unknown.Historical quality control results indicated that three of the four vitros phyt slide lots were exhibiting some magnitude of within-lab imprecision within the timeframe of the event.Since three different vitros phyt slide lots were affected, it is unlikely a slide related issue contributed to the event, however, slide related issues cannot be completely ruled out as contributing to the event.In addition, ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros phyt reagent.The tsc did not investigate the customer¿s sample handling protocol, therefore, improper pre-analytical sample handling protocol cannot be ruled out as contributing to the event.Finally, an ortho fe replaced the immunowash metering pump of the vitros 5600 system, however, since the pre-service vitros crbm and phyt within-run precision tests were acceptable, it is unknown if an analyzer related issue contributed to the event.Acceptable vitros phyt performance has been observed since the service action performed on 14 june 2018.
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