This report is being filed to provide additional information.Investigation: the customer did not provide the lot number pertaining to this event,therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause: there was no run data file (rdf) available for analysis, therefore, root causeremains undetermined at this time.Possible causes for the elevated wbc count include the following: rbc spill over, centrifuge stopped, rbc detector calibration error, possible air block donor physiology sampling, calculation, or other process error.
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