A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.No non-conformances or deviations associated with the affected reagent lot were identified.An in-house retained reagent kit of architect ca 19-9xr reagent, lot number 73036m800, was tested in an accuracy performance setup.Results from this testing did not implicate that the accuracy performance of the lot is negatively impacted.All acceptance criteria met specifications.No returns were made available from the customer site.The architect ca 19-9xr assay package insert contains information to address the current customer issue.Based on the results of this evaluation and the information from the customer site, no systemic issue or product deficiency was identified.This report is being filed on an international product, list number 02k91-32, that has a similar product distributed in the us, list number 02k91-29.Pt identifier: sid (b)(6).This issue was previously reported under mdr number 3002809144-2017-00114 under a different suspect device manufacturer.
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