Further investigation of the issue included a review of the complaint text, a search for similar complaints, in-house testing and a review of labeling.Additional information provided in the complaint text indicated the customer confirmed that the false elevated result was due to an incident with the specimen i.E.Fibrin had adhered to the probe and caused issues at the wash zone leading to elevated rlu values.Review of complaint activity determined that there is normal complaint activity for likely cause lot 70095fn00.Tracking and trending report review for the architect afp assay determined that there are no related adverse or non-statistical trends.Using world wide field data the historical performance of reagent lot 70095fn00 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 lot 70095fn00 was similar to the other architect afp reagent lots.Therefore, no unusual reagent lot performance was identified for lot 70095fn00.Testing of a serum based panel sample with a target to a known concentration, was performed using an in-house retained kit of lot 70095fn00.All specifications were met indicating that lot 70095fn00 is performing acceptably.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect afp assay was identified.Correction: lot number was initially reported in serial number field.The lot number has been entered in the correct field.
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