The initial reporter complained of questionable thyroid results compared wako accuraseed for 1 patient sample tested on a cobas 8000 e 801 module.The patient sample was submitted for investigation.There were discrepant results identified for ft3 iii and tsh assays between the customer's e 801 module, an e 801 module used at the investigation site, and the wako accuraseed.There were discrepant results identified for ft4 iii on the customer's e 801 between elecsys ft4 ii assay on an e 801 module used at the investigation site and wako accuraseed.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft4ii results, medwatch with patient identifier (b)(6) for information on the ft4 iii results, and medwatch with patient identifier (b)(6) for information on the ft3 iii results.The results from the customer site were reported outside of the laboratory.Refer to the attachment to the medwatch for all patient data.The e 801 module serial number was (b)(4).
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