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, field data history of alinity s chagas reagent, lot number 26408be00.The ticket search determined that there is normal complaint activity for the likely cause lot.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 complaint lot and complaint issue.The customer data review for alinity s chagas reagent, lot number 26408be00 was performed.The analysis included initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming zero prevalence) across all us customer sites and whole blood (wb) peer sites connected to the abbottlink data retrieval system and using these lots.As the alinity s instruments at the customer site are not connected to abbottlink a historical analysis specific to the customer site could not be performed.A aggregated performance of lot 26408be00 across all customer sites and wb peer sites is within product requirements and comparable to the performance of other lots of the same assay evaluated in the comparison (irr: 0.000 to 0.112%; rrr: 0.000 to 0.110%; specificity: 99.890 to 100.000%).All data review indicating that the reagent performing as expected.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity s chagas reagent, lot number 26408be00.
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