This report is being filed on an international product, alinity i anti-hcv, list 8p06, that has a similar product distributed in the us, anti-hcv, list number 8p05.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
|
The evaluation of the customers issue 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 testing of a retained kit sample of the complaint lot number.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review determined no trend for the customer¿s issue for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.File kit testing showed acceptable results.Labeling review concludes that the issue is adequately addressed.Based on our investigation, no systemic issue or deficiency was identified.
|