The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 assay on a cobas 8000 e 801 module and a second e 801 analyzer used for investigation.No alleged erroneous results were reported outside of the laboratory.This medwatch will apply to the tsh assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2020.The sample was repeated on a siemens centaur and an abbott architect analyzer.The sample was also provided for investigation where it was tested on a second e 801 analyzer on (b)(6) 2020.The serial number of the customer's e 801 analyzer is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Tsh reagent lot number 416233, with an expiration date of october 2020 was used on this analyzer.
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