ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I HBSAG QUALITATIVE II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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Catalog Number 08P10-21 |
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 12/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = (b)(6) all available patient information was included.Additional patient details are not available.
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Event Description
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The customer observed a false reactive alinity i hbsag qualitative ii result for a patient in the dialysis unit.The following data was provided: initial result a week ago = negative, hep b vaccine administered.(b)(6)2023 same patient, new sample.Result = positive for both hep b antigen and antibody.Sample id (b)(4)initial result = reactive.Repeat in duplicate and both results = reactive.Confirmatory test performed and result = reactive.No impact to patient management was reported.
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Manufacturer Narrative
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The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in house testing of a retained reagent kit.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Clinical specificity testing was performed using an in-house retained kit of the complaint lot.All specifications were met indicating that lot 55622fn00 is performing acceptably and there is no issue with the lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i hbsag qualitative ii reagent lot 55622fn00 and was identified.
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Event Description
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The customer observed a false reactive alinity i hbsag qualitative ii result for a patient in the dialysis unit.The following data was provided: initial result a week ago = negative, hep b vaccine administered.(b)(6) 2023 same patient, new sample.Result = positive for both hep b antigen and antibody.Sample id (b)(6) initial result = reactive.Repeat in duplicate and both results = reactive.Confirmatory test performed and result = reactive.No impact to patient management was reported.
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