ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I ANTI-HBS REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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Catalog Number 07P89-78 |
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 06/12/2023 |
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.Section a1 - patient identifier complete entry = sample #1 and sample #2.All available patient information was included.Additional patient details are not available.Section e1 - phone complete entry = (b)(6).This report is being filed on an international product, list number 07p89-78, that has a similar product distributed in the us, list number 07p88.
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Event Description
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The customer observed falsely elevated alinity i anti-hbs results for two patients.The following data was provided (>/=10.0 miu/ml is considered protected): sample #1 initial result was 374.89, repeat, after re-centrifuging, was 285.67 miu/ml sample #2 initial result was 39.7, repeat, after re-centrifuging, was 35.65 miu/ml the samples were repeated using the sym-bio platform and the results were negative.There was no impact to patient management reported.
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Event Description
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The customer observed falsely elevated alinity i anti-hbs results for two patients.The following data was provided (>/=10.0 miu/ml is considered protected): sample #1 initial result was 374.89, repeat, after re-centrifuging, was 285.67 miu/ml sample #2 initial result was 39.7, repeat, after re-centrifuging, was 35.65 miu/ml the samples were repeated using the sym-bio platform and the results were negative.There was no impact to patient management reported.
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Manufacturer Narrative
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The complaint investigation for a falsely elevated alinity i anti-hbs result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Specificity testing was performed using an in-house retained kit of lot 46374fn01, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i anti-hbs, lot number 46374fn01, was identified.
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