The complaint investigation for falsely elevated calcium results generated on the alinity c processing module 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 review of tracking and trending did not identify any trends for the complaint issue.Device history record review by lot did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency of the calcium assay was identified.All available patient information was included.Additional patient details are not available.
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