ABBOTT GMBH ALINITY I TOXO IGG REAGENT KIT; ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
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Catalog Number 07P45-32 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/25/2022 |
Event Type
malfunction
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Event Description
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The customer observed false reactive alinity i toxo igg results for two patients.The following data was provided: processed (b)(6) 2022, sid (b)(6), initial = 10.19 iu/ml, repeat = 0.10, patient history = <0.20.Processed (b)(6) 2022, sid (b)(6), initial = 3.75 iu/ml, repeat = 0.08, patient history = <0.20.<1.6 iu/ml = negative.1.6 to < 3.0 iu/ml = gray area.= 3.0 iu/ml = positive no impact to patient management was reported.
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Manufacturer Narrative
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This report is being filed on an international product, list number (b)(4), that has a similar product distributed in the us, list number (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for patient information patient identifier= sid (b)(6).
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Manufacturer Narrative
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The complaint investigation for false reactive alinity i toxo igg results, using reagent lot number 44254be00, 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.Return testing was not completed as returns were not available.Ticket search by lot indicates that the reagent lot shows slightly higher complaint activity than expected.Ticket review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 44254be00 and the complaint issue.Labeling was reviewed and found to be adequate.In-house testing of a retained reagent kit of the complaint lot was performed.All specifications were met, and no false reactive results were obtained, showing that the lot generates the expected results.Based on our investigation, no systemic issue or deficiency with the alinity i toxo igg reagent for lot 44254be00 was identified section h6 medical device problem code corrected from a090804-false positive results to a090809-high test results.
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