The investigation determined that higher and lower than expected vitros lac quality control results were obtained from vitros control fluids using two different lots of vitros lac slides on a vitros 350 chemistry system.A definitive assignable cause could not be determined.There is no evidence that a vitros 350 system occurred.The unacceptable historical vitros lac quality control results obtained from the customer indicate that the vitros lac lot 3530-0092-3271 was not performing as intended.However, it is suspected that the customer is not following correct protocol when reconstituting the calibrator and control fluids but could not be confirmed.
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