The initial reporter received questionable elecsys ft3 iii assay results for 1 patient sample on a cobas e 801 module, serial number (b)(4).This medwatch covers the alleged results for the ft3 assay.Please refer to the medwatch with patient identifier (b)(6) for the alleged ft4 assay results.(b)(4).The results were reported to the patient's physician, who requested the sample test be repeated.
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The customer's calibration and qc were requested but not provided.Based on the available information, a general reagent issue can be excluded.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials and the standardization methodology used.The investigation did not identify a product problem.
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