The customer obtained a discordant, negative vitros op-lo result from a single patient sample run on the vitros 5600 integrated system, when compared to a positive opiate result obtained using the gc/ms method.Vitros patient result: 277 ng/ml (positive cutoff >or = 300 ng/ml) vs.>12000 ng/ml (positive).Biased results of the magnitude and direction observed may lead to inappropriate physician action.It is not known if the discordant vitros op-lo result was reported out of the laboratory.There was no report of treatment started, stopped, or altered based on the false negative vitros op-lo result and there was no report of patient harm as a result of this event.(b)(4).
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