Section d10 - concomitant product: additional product added: cc bilirubin cal(6x5ml),01e66-05,97449fd01.The complaint investigation for falsely decreased total bilirubin results, while using total bilirubin reagent lot 62321uq07 with architect bilirubin calibrator lot 97449fd01, included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history records review.Return testing was not completed as returns were not available.Trending review 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 likely cause lot and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.All release criteria were met and the product continues to perform within specifications.However, a notification letter was provided to customers to explain the potential for lower recovery in total bilirubin results when using architect bilirubin calibrator specific lot numbers (including lot 97449fd01 in use at the customer site).The architect bilirubin calibrator lot 97449fd01 is performing as expected.Based on our investigation, no systemic issue or deficiency was identified for the total bilirubin reagent lot 62321uq07 when used with architect bilirubin calibrator lot 97449fd01.
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