The complaint investigation for falsely elevated alinity i afp results 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 field data review.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any related trends for the product for the issue.Device history record review on lot 44843fn00 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Field data was used to assess the performance of the alinity i afp assay.Review shows that the median patient result for lot 44843fn00 falls within 1sd of the established baseline, indicating the reagent lot is performing acceptably on market.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity i afp for lot number 44843fn00 was identified.
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