Health effect impact code: f26 component code: g01003 d8: was this device serviced by a third party?: no the complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review of the architect afp reagent lot number 19466fn00.The ticket search determined that there is normal complaint activity for the likely cause architect afp lot 19466fn00.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.Historical performance of architect afp reagent was evaluated using world wide data from abbottlink.This evaluation indicated that the patient median for lot 19466fn00 are within the established limits, therefore, no unusual reagent lot performance was identified.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Per product labeling, inadequate centrifugation or the presence of fibrin or particulate matter in the sample may cause an erroneous result.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 afp reagent, lot 19466fn00.
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