The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.A search for similar complaints and ticket trending review did not identify any trends or issues with the complaint lot number or current complaint issue.Device history record review did not identify any non-conformances or deviations related to the complaint lot and complaint issue.The historical performance of reagent lot 43489ud00 was evaluated using data from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 43489ud00 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 43489ud00.Labeling was reviewed and was found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency was identified for the alinity c magnesium reagent, lot 43489ud00.
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