The investigation could not identify a product problem.The difference in values relates to the setups of the assays, the antibodies used, and differences in the standardization materials and procedures used.The presence of an interfering factor in the sample can most likely be excluded.
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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 module analyzers.No incorrect results were reported outside of the laboratory.Refer to the attachment for all patient data.The customer initially tested the sample on their e 801 analyzer on (b)(6) 2022.The sample was provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2022.The sample was also repeated on an abbott architect analyzer.The serial number of the customer's e 801 analyzer is (b)(4).The ft4 reagent lot number and expiration date used on this analyzer were requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number: 630888, with an expiration date of 31-may-2023 was used on this analyzer.
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