This event occurred in (b)(6).Customer's calibration and qc data were requested but not provided.The observed differences in ft4 values generated with the roche assay, accuraseed assay, and architect assay are most likely caused by differences in the overall setups of the assays, the antibodies used, differences in reference materials, and the differences in the standardization methodology used.Based on the available data, the investigation did not identify a product problem.The cause of the event could not be determined.
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