This event occurred in (b)(6).To the differences of the different values generated with the different analyzers, it needs to be taken into account that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.From the information provided and the analysis thereof, a general reagent issue can most likely be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.
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