The user stated the sample was judged "positive" with flags, however the flags were not provided for evaluation.The sysmex xn-1000 instructions for use (ifu), chapter 11 - checking detailed analysis information (data browser), section 11.6 - ip messages, details the method in which the analyzer conveys its findings.Results without an error message are categorized as "positive" or "negative" based upon preset criteria, some of which are user-defined.The system bases judgments on comprehensive surveys of numerical data, particle-size distributions, and scattergrams.Flags and messages, communicated through ip messages, indicate the analyzer's findings and notify the user of possible sample specific abnormalities.The analyzer alerted the operator to possible sample abnormality requiring verification prior to reporting of results.Chapter 9 - analyzing samples, section 9.3 - manual analysis, explains: "if you will not scan a barcode, enter the sample number manually in the input field." it is the responsibility of the operator to ensure the correct sample id is entered into the analyzer.Good laboratory practice requires that the user properly identifies samples.No analyzer deficiency was identified.User error caused this event.
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