The investigation included review of product historical data, product labeling, and review of the incident.Review of product historical data and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.Manufacturing documentation for the analyzer was reviewed and did not identify any issues related to the complaint issue.Review of the incident found the technician was not wearing eye protection.Additionally, it was noted that the field service technician is required to power down/de-pressurize the instrument prior to servicing the reagent panel.Review of labeling sufficiently addresses the issue.The cell-dyn sapphire operator's manual indicates, the user should consider all clinical specimens, reagents, calibrators, and controls that contain human-sourced materials as potentially infectious.Consider all system surfaces or components that have come in contact with human sourced materials as potentially infectious.Additionally, the manual states operators have to make sure they are wearing eye protection and other personal protective clothing.Based on the investigation no product deficiency was identified for the cell-dyn sapphire analyzer.
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