The complaint investigation included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records, and accuracy testing of reagent lot 14665fp00.Return testing was not completed as returns were not available.Review of complaint activity and trending data did not identify any issues or trends.Device history review for lot 14665fp00 did not identify any issues.Labeling was reviewed and sufficiently addresses the customer issue.Accuracy testing was performed using a retained kit of reagent lot 14665fp00.An internal alinity i ca19-9xr panel which was tested with the complaint lot.Acceptance criteria were met, which indicates acceptable product performance.Based on the investigation no systemic issue or deficiency of the alinity i ca19-9xr lot was identified.
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