Unique identifier (udi) # (b)(4).This event occurred in (b)(6).From the information provided and analysis, a general reagent issue can be excluded.To the differences of the ft4 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.The investigation did not identify a product problem.The cause of the event could not be determined.
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