This event occurred in (b)(6).The ft4 reagent used during investigation was lot was 459257 with an expiration date of 30-feb-2021.Based on the data provided, a general reagent issue can be excluded.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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