All available patient information is included.Additional patient details are not available.This report is being filed on an international product, list number 08d06-74 that has a similar product distributed in the us, list number 8d06-31 / 41.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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The complaint investigation for false nonreactive architect syphilis tp results included a search for similar complaints, and the review of complaint text, trending data, labeling, in-house testing, and device history records.Return testing was not performed as returns were not available.A review of tracking and trending did not identify any related trends for the product for the complaint.The device history record was reviewed and did not identify any non-conformances or deviations associated with the reagent lot number and complaint issue.In-house testing was performed on a retained reagent kit of the complaint lot in a sensitivity set up.All controls met specifications and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect syphilis tp reagent lot 37015be01 was identified.
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