The customer obtained two lower than expected phyt quality control results using a vitros 5600 integrated system (units are g/ml): qc l3 vitros results of 11.7 and 10.9 g/ml versus expected value of 20.84 g/ml.Biased results of the direction and magnitude observed could lead to inappropriate physician action.There was no report that patient samples were affected and no allegation of patient harm as a cause of this event.However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected.This report is number one of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.(b)(4).
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