ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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Catalog Number 06C36-76 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2023 |
Event Type
malfunction
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Event Description
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The customer reported false positive architect hbsag results have skewed high.The customer indicated that the impacted patients have been previously tested and confirmed positive with confirmatory testing for hbsag.There was no reported impact to patient management.
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Manufacturer Narrative
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This report is being filed on an international product, list number 6c36 and there is a similar product distributed in the u.S., list number 4p53.E1 phone number: complete phone number is (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Manufacturer Narrative
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Additional information received from customer: the customer clarified that the assay was not being used for monitoring hbsag and that the impacted patients have not been previously tested and confirmed positive with confirmatory testing for hbsag.Based upon this new information, this complaint is no longer a reportable event.Additional information updated in fields, b5, h3, and h6 h3 other text : additional information received from customer: the customer clarified that the assay was not being used for monitoring hbsag and that the impacted patients have not been previously tested and confirmed positive with confirmatory testing for hbsag.Based upon this new information, this complaint is no longer a reportable event.
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Event Description
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The customer reported false positive architect hbsag results have skewed high.The customer indicated that the impacted patients have been previously tested and confirmed positive with confirmatory testing for hbsag.There was no reported impact to patient management.Update: on (b)(6) 2023, the customer clarified that the assay was not being used for monitoring hbsag and that the impacted patients have not been previously tested and confirmed positive with confirmatory testing for hbsag.
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