ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG QUALITATIVE II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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Catalog Number 02G22-25 |
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 11/01/2023 |
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 2g22 that has a similar product distributed in the us, list number 4p53.
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Event Description
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A journal article by marina bubonja-sonjea,dolores peru, maja abram, bojana mohar-vitezi.¿prevalence of occult hepatitis b virus infection and characterisation of hepatitis b surface antigen mutants among adults in western croatia¿, annals of hepatology, volume 29, issue 1, january¿february 2024, 101156.Documented false positive architect anti-hbc ii and false negative architect hbsag qualitative ii results.No impact to patient management was reported.
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Event Description
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A journal article by marina bubonja-sonjea,dolores peru, maja abram, bojana mohar-vitezi.¿prevalence of occult hepatitis b virus infection and characterisation of hepatitis b surface antigen mutants among adults in western croatia¿, annals of hepatology, volume 29, issue 1, january¿february 2024, 101156.Documented false positive architect anti-hbc ii and false negative architect hbsag qualitative ii results.No impact to patient management was reported.
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Manufacturer Narrative
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The complaint investigation was performed for false nonreactive results with the architect hbsag qualitative ii assay (lot# unknown) which included a review of data and information provided in the article, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Trending review determined no trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the likely cause list number and complaint issue.The overall performance of architect hbsag qualitative ii reagents in the field was reviewed using data gathered from customers worldwide and suggested that the performance is acceptable.Labeling review concluded that the issue is adequately addressed.Based on our investigation, no systemic issue or product deficiency of the architect hbsag qualitative ii reagent was identified.
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