ABBOTT GMBH ARCHITECT SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
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Catalog Number 08D06-77 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 8d06-39 has a similar product distributed in the us, list number 8d06-31/-41.
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Event Description
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The customer observed false nonreactive architect syphilis results generated for a 70 year old female patient.The following data was provided: (b)(6) 2022 initial result = 0.89 s/co, repeat = 0.95 s/co, repeat with another method (fluorescence) = 19.21 (positive), tppa = positive.No impact to patient management was reported.
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Manufacturer Narrative
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The complaint investigation for falsely reactive architect syphilis results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history review, and in house testing was completed.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 lot 32478be01 and the complaint issue.In-house specificity testing was completed with complaint lot number 32478be01.All controls met specifications and no false reactive results were obtained, indicating that the specificity performance is not negatively impacted.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the architect syphilis reagent for lot 32478be01 was identified.
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Search Alerts/Recalls
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