The complaint investigation for a false positive result 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 and field data review for lot 12124ui00.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 with lot 12124ui00.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 is acceptable.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 total b-hcg reagent, lot 12124ui00.
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