The investigation determined that the customer obtained higher and lower than expected vitros lactate quality control (qc) results using the vitros 5600 integrated system.The assignable cause of the event is most likely the use of sub-optimal calibrations that subsequently caused the higher and lower than expected lactate quality control results.The customer obtained multiple sub-optimal calibration parameters when compared to expected parameters using the same vitros lactate lot with three different calibrator kit lots and therefore, it is not likely that the issue was related to the calibrator kit lots themselves.Improper pre-analytical calibrator fluid handling is a likely contributing factor, but this could not be definitively confirmed.A successful recalibration using the same lactate lot was obtained with no changes to the instrument or the lactate reagent.A malfunction of the vitros 5600 integrated systems or a vitros lac reagent lot issue are not likely contributors to this event.
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