Postal code = (b)(6), a leading zero was added to the field to meet the 5 digit requirement.The complaint investigation for falsely decreased patient results when using alinity c carbon dioxide, lot number 57109uq03, 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 determined no related trends for the product.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review on lot number 57109uq03 did not identify any non-conformances or deviations with the likely cause lot.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the alinity c carbon dioxide assay was identified.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity c carbon dioxide was identified.
|