The investigation could not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.This event occurred in (b)(6).(b)(4).
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The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ft4 iii assay on two cobas 8000 e 801 modules.No incorrect values were reported outside of the laboratory.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2020.The sample was repeated on a siemens centaur analyzer.The sample was also provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2020.The e 801 analyzer used at the customer site is serial number (b)(4).The e 801 analyzer used for investigation is serial number (b)(4).Ft4 reagent lot number 460793, with an expiration date of february 2021 was used on this analyzer.
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