Catalog Number 08P11-22 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being filed on an international product, alinity i hbsag qualitative ii confirmatory, list 08p11-22, that has a similar product distributed in the us, list number 08p11-21.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No further information was provided.Refer to related manufacturer report number 3008344661-2020-00006 for the device evaluation of a second lot of alinity i hbsag qualitative ii confirmatory; 3008344661-2020-00002 and 3008344661-2020-00005 for the device evaluation of the alinity i hbsag qualitative ii reagent lots.
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Event Description
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The customer reported false repeat reactive and confirmatory positive alinity i hbsag results.Sample id (b)(6) generated 2.33 and 2.45 s/co on the hbsag assay and multiple confirmed results with neutralization results ranging from 101 to 103% neutralization.The sample was tested at a reference lab and generated negative results on architect hbsag quantitative, architect hbsag confirmatory, and elisa methods.No impact to patient management was reported.
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Manufacturer Narrative
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The data associated with the discrepant results were reviewed.There were no issues with the calibrations performed using the reagent lots.There were no issues with negative and positive control values on the dates the sample was tested.However, it was noted that the control lot (8p10-10 lot 96285fn00) was expired (15 sep 19).Review of complaint activity associated with the complaint lots identified normal complaint activity.Review of tracking and trending reports for the alinity i hbsag qualitative ii confirmatory assay did not identify any related trends.Return testing was not completed as returns were not available.Testing of negative panels, which mimics patient samples, was performed using an in-house retained kit of lot 07057fn00 stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Manufacturing documentation for the likely cause lots were reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect hbsag qualitative ii confirmatory assay was identified.
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Search Alerts/Recalls
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