The complaint investigation for falsely depressed architect 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 trends for the complaint issue.The device history record review was performed on list 3p36 as the lot is unknown.The search did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Customer field data was used to assess the performance of the architect afp assay using worldwide data.Review shows that the median patient result for list 3p36 is within established limits and comparable, confirming no systemic issue.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency of the architect afp assay was identified.All available patient information was included.Additional patient details are not available.
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