The complaint investigation for false reactive alinity i hbsag qualitative ii confirmatory 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 return testing.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations for alinity i hbsag qualitative ii confirmatory reagent 08p11 and the complaint issue.Customer returns analysis was performed with patient specimens (ids (b)(6) ).The return specimens (ids (b)(6) ) generated repeat reactive results when tested with alinity i hbsag qualitative ii reagent, lot 44577fn00, but were not confirmed inhouse when tested with alinity i hbsag qualitative ii confirmatory reagent 08p11.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the alinity i hbsag qualitative ii confirmatory reagent 08p11 was identified.
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