After review of this submission, it was discovered section a1 - patient identifier needed to be updated to document the multiple sample ids noted in section b5.Correction to section a1 updated to multiple and include here the complete sample ids: (b)(6); (total of 5 different patients).The complaint investigation for falsely elevated architect free t4 results included a search for similar complaints, and the review of complaint text, trending data, labeling, and in-house testing.Return testing was not performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A search for similar complaints did identify an increase in complaint activity for lot 56001ud00, however, no related trends were identified regarding commonalities for complaint lot number and issue.Additionally, in-house performance testing was completed which indicates the product is performing as expected.A review of device history record did not identify any non-conformances or deviations associated with the list number and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for architect free t4 reagent lot 56001ud00.
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