The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labelling review, device history record review, field data review and in house testing of retained kits with the complaint lot number.Return testing was not completed as returns were not available.Review of complaint activity and trending reports did not identify any issues or trends.Device history record review for the complaint lot did not identify any non-conformances or deviations.In house testing was performed using a retained kit of the complaint lot.All criteria were met indicating acceptable product performance.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered from customers worldwide.The median patient results of the positive population were within the acceptable, indicating the performance of the lot is acceptable.Based on our investigation, no systemic issue or deficiency of the architect total b-hcg reagent lot was identified.D4 expiration date changed from 01/25/2021 to 01/21/2021 due to an entry error.
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