The investigation determined that higher than expected amon results were obtained from non-vitros biorad lot 54140 quality control fluids processed using vitros amon slides with a vitros 5600 integrated system.The assignable cause is user error, associated with calibration.The customer calibrated the vitros amon slides using calibrator kit 1, when the valid calibrator kit for the vitros amon assay is calibrator kit 5.Acceptable vitros amon performance was obtained after restoring a previous calibration generated using calibrator kit 5.
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A customer obtained higher than expected ammonia (amon) results from non-vitros biorad lot 54140 quality control fluids (level 1= >500, >500, >500 versus expected 25.23 umol/l; level 3= >500, >500 versus expected 231.8 umol/l) using vitros amon slides in combination with a vitros 5600 integrated system.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.There was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.(b)(4).
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