ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
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Catalog Number 07P60-74 |
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 12/20/2023 |
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.All available patient information was included.Additional patient details are not available. note: this report is being filed on an international product, list number 07p60-74, which has a similar product distributed in the us, list number 07p60-21/-31.
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Event Description
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The customer observed false non-reactive alinity i syphilis tp result for a patient sample.The following data was provided (reference range 1.0 s/co is nonreactive): initial result = 0.70 s/co.Elisa results = positive, tppa results = positive, rpr results = negative.No impact to patient management was reported.
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Event Description
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The customer observed false non-reactive alinity i syphilis tp result for a patient sample.The following data was provided (reference range <1.0 s/co is nonreactive): initial result = 0.70 s/co.Elisa results = positive, tppa results = positive, rpr results = negative.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.Ticket search by lot indicates the reagent lot is performing as expected for this product.A review of tracking and trending did not identify any trends for the issue for the product.Device history record review for lot 52338be01 did not identify any non-conformances or deviations with the complaint lot.In-house testing of a retained reagent kit of the complaint lot was performed.All specifications were met, and no false non-reactive results were obtained, indicating that the lot generates the expected results.(note: lot 52338be01 is a china specific lot and is identical to lot 52338be00.Both contain the same bulk material and are identical except the labeling of the outer package).Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency with the alinity i syphilis tp reagent lot 52338be01, was identified.
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