Review of complaint activity did not identify any adverse or non-statistical trends for the architect cyclosporine assay.An increase in complaint activity was not identified for reagent lot 88026m800.Accuracy testing was also performed to evaluate the performance of reagent lot 88026m800.An internal panel was tested with retained kits of the likely cause reagent lot.Acceptance criteria was met, which indicates acceptable product performance.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect cyclosporine assay was identified.
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