The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ft4 iii assay on two cobas 8000 e 602 module analyzers.The values measured at the customer site were reported outside of the laboratory to a physician.The sample was tested on the customer's e 602 analyzer on (b)(6) 2021, resulting with a ft4 value of 2.10 ng/dl (reference range =.90 - 1.70 ng/dl).The sample was repeated on an abbott architect analyzer, resulting with a value of 1.43 ng/dl (reference range = 0.70 - 1.48 ng/dl).The sample was also provided for investigation, where it was tested on a second e 602 analyzer on (b)(6) 2021, resulting with a value of 1.88 ng/dl.The serial number of the customer's e 602 analyzer is (b)(4).Ft4 reagent lot number 478085, with an expiration date of may 2021 was used on this analyzer.The serial number of the e 602 analyzer used for investigation is (b)(4).Ft4 reagent lot number 478085, with an expiration date of may 2021 was used on this analyzer.
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