ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
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Catalog Number 07P60-77 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2022 |
Event Type
malfunction
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Event Description
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The customer observed false nonreactive alinity i syphilis tp results for 68-year-old female patient.The customer is not sure which result is correct.The patient had a blood transfusion in june.The following data was provided: sid: (b)(6) alinity i syphilis tp 0.48 s/co (nonreactive), johnson 5.59 s/co, trust negative, tppa 1:80, colloidal gold negative.No impact to patient management was reported.
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Manufacturer Narrative
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All patient information is provided.No additional information 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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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 reagent lot performs as expected for this product.Return testing was not performed as returns were not available.Device history record review was performed on lot 37020be01, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.In-house testing of retained reagent kits of the complaint lot was performed.All specifications were met and no false non-reactive results were obtained, showing that the lot generates the expected results.Labeling review concludes that the issue is adequately addressed.Based on all reviewed data, we conclude that there is no product deficiency with the alinity i syphilis tp reagent identified in this complaint.
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Search Alerts/Recalls
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