The complaint investigation for falsely elevated alinity c calcium results 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.Trending review by did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with list number 07p57 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.As part of troubleshooting, the patient samples were repeated and gave acceptable results.Based on our investigation, no systemic issue or deficiency with the alinity c calcium assay was identified.
|