Investigation of the customers issue included a review of the complaint text, a search for similar complaints, in-house testing, review of field data, manufacturing documentation and labeling.Return testing was not completed as returns were not available.Review of complaint activity determined that there was normal complaint activity for reagent lot 96194fn00.Tracking and trending report review for the architect afp assay determined that there are no related trends.Using worldwide field data the historical performance of reagent lot 96194fn00 was evaluated and compared to the performance of all architect afp reagent lots in the field.This evaluation indicated that the patient median result for the lot was within 3sd of the established baseline.The reagent lot was further evaluated, an in-house retained kit of reagent lot 96194fn00 was used to test a panel of known concentration.All specifications were met indicating the lot was performing acceptably.Manufacturing documentation for the lot did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect afp assay was identified.
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