SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2); TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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Model Number N/A |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2024 |
Event Type
malfunction
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Event Description
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The customer reports observation of reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2) results which were discordant relative to alternate-method testing.Ahbs2 kit lot 164 was in use at the time.The customer obtained reproducible reactive ahbs2 results on three test dates for a 30-year-old male patient.Repeat testing using two alternate methods produced negative results which conflicted with the earlier reactive results.The customer is uncertain which results to consider correct.Due to the conflicting indications, the reactive atellica im ahbs2 results are considered potential false positive observations.There are no allegations of any adverse patient consequences in association with the observed discordance.Quality control (qc) results were within expected ranges when these ahbs2 tests were run.
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Manufacturer Narrative
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A customer from outside the united sates reported observation of a reactive (positive) atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to alternate-method testing.The atellica im ahbs2 instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.
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Search Alerts/Recalls
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