Additional information section: d4 - expiration date and h4 - device mfg date.The complaint investigation for falsely elevated magnesium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the complaint lot.The overall performance of architect magnesium reagents was reviewed using data gathered from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 39431ud00.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the architect magnesium reagent kit, lot number 39431ud00, was identified.
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