The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and in-house testing of architect cyclosporine reagent lot 25039m800.The ticket search determined that there is normal complaint activity for the likely cause lot.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.A specificity testing was performed on internal cyclosporine panels with a retained kit of lot 25039m800.All validity and acceptance criteria were met during completion of the protocol, demonstrating that the lot is performing as expected.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect cyclosporine reagent lot 25039m800.
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