The customer observed higher and lower than expected vitros lac quality control results from vitros control fluids using two different lots of vitros lac slides on a vitros 350 chemistry system.Vitros lac lot 3530-0092-3271.Pv2 lot k4852 vitros lac result 2.58*, 2.64*, 2.61*, 2.62*, 2.37*, 2.58*, 2.60*, 2.59*, 2.60*, 2.56*, 2.64*, 2.62*, 2.58*, 2.60*, and 2.61* mmol/l ,versus the expected vitros lac result 3.96 mmol/l.Pv2 lot m5007 vitros lac results 5.09*, 2.54* and 5.19* mmol/l versus the expected vitros lac result 3.76 mmol/l.Vitros lac lot 3531-0093-5063.Pv1 lot l5005 vitros lac result 2.13* mmol/l versus the expected vitros lac result 1.39 mmol/l.Pv2 lot m5007 vitros lac result 5.67* mmol/l versus the expected vitros lac result 3.33 mmol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action.Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected and would not be affected if the event were to recur undetected.There were no allegations of patient harm.This report is number eleven of twenty mdr's for this event.Twenty 3500a forms are being submitted for this event as twenty devices were involved.This report corresponds to ortho clinical diagnostics inc.(b)(4).
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