The complaint investigation for a false elevated result for one patient when tested with the architect total b-hcg assay included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labelling review, device history record review, field data review and in house testing of retained kits of lot 11237ui00.Return testing was not completed as returns were not available.Trending review determined no trends for the product.Device history record review did not identify any non-conformances or deviations for lot 11237ui00.In house testing of retained kits determined that the specificity performance of the lot is not negatively impacted.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered via abbottlink from customers worldwide and suggested that the performance of the lot is acceptable.Labelling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency of the architect total b-hcg reagent, lot 11237ui00, was identified.
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