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 11/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Mdr: this report is being filed on an international product list 7p60, that has a similar us product distributed in the us, list 07p60-21 / 31.Patient identifier of multiple is sids (b)(6), (b)(6) male, (b)(6) male, race/ethnicity not provided.Phone does not allow enough character spaces, the entire phone is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Event Description
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The account generated (b)(6) alinity i syphilis tp (b)(6) results on 2 patients, sids (b)(6), ((b)(6) male, (b)(6) male) that repeated (b)(6) but tested colloidal gold method (b)(6) and tppa method weak (b)(6).No impact to patient management was reported.
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Manufacturer Narrative
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Section g1, contact name, email, address, phone, fax updated.The ticket search by lot indicates that the reagent lot performs as expected for this product.The ticket trending review of complaint data for the likely cause list number does not identify any adverse trend.Labeling review concludes that the issue is adequately addressed.A review in the corrective and preventive actions system does not identify any non-conformances or deviations associated with the likely cause lot number and complaint issue.A retained reagent kit of the complaint lot was tested in a sensitivity setup.All specifications were met and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.No product deficiency was identified.Section g1, contact name, email, address, phone, fax updated.
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Search Alerts/Recalls
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