Field service engineer (fse) visited the site, replaced counting chamber and the external power supply, however; the issue was not resolved.Fse performed a complete check of the system including shielding and all plug contacts, reinstalled software 1.1.5, performed annual maintenance, run precision and qc, all ok.A review of all tickets and a review for complaint trends for the list numbers were performed.The review did not identify any issues or trends.Device history record review did not identify any non-conformances or deviations related to the product and complaint issue.Labeling was found to adequately address the issue.Based on the investigation, no systemic issue or deficiency for the cell-dyn emerald 22 al analyzer, sn (b)(6), was identified.
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