Catalog Number 06P06-60 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/02/2023 |
Event Type
malfunction
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Event Description
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The customer reported a false reactive alinity s anti-hbc result on a donor.In (b)(6) 2023 alinity was reactive; in (b)(6) 2023 was nonreactive; in (b)(6) 2023 was reactive, another laboratory was negative for anti-hbc.Results provided: (b)(6) 2023 sid (b)(6) = 1.06 / 1.06 / 1.06 s/co.(b)(6) 2023 sid (b)(6) = 0.84 s/co.(b)(6) 2023 sid (b)(6) = 1.05 / 1.02 / 1.02 s/co.No impact to donor management was reported.
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Manufacturer Narrative
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An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Section a1 patient identifier sids: (b)(6)2023 (b)(6), 04may2023 (b)(6), (b)(6)023 sid (b)(6).
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Manufacturer Narrative
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See mr# 3002809144-2023-00457 for other lot#.Section d4 corrected lot# from 43080be00 to 40478be00.
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Event Description
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The customer reported a false reactive alinity s anti-hbc result on a donor.In (b)(6) 2023 alinity was reactive; in (b)(6) 2023 was nonreactive; in (b)(6) 2023 was reactive, another laboratory was negative for anti-hbc.Results provided: (b)(6) 2023 sid (b)(6) = 1.06 / 1.06 / 1.06 s/co.(b)(6) 2023 sid (b)(6) = 0.84 s/co.(b)(6) 2023 sid (b)(6) = 1.05 / 1.02 / 1.02 s/co.No impact to donor management was reported.
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Manufacturer Narrative
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A complaint investigation for false nonreactive results for alinity s anti-hbc included a review of trending data, labeling, device history record, field data, and a complaint search.No customer returns were available for evaluation.The complaint data for the product identified normal complaint activity for the complaint issue and no trends were identified.Labeling review concluded the labeling adequately addresses the issue.A device history record review did not identify any non-conformances or deviations.Based on the results of this investigation, alinity s anti-hbc reagent, lot 40478be00 is performing as expected and no systemic issue or product deficiency was identified.Section d4 lot# updated from 43080be00 to 40478be00.
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Event Description
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The customer reported a false reactive alinity s anti-hbc result on a donor.In (b)(6) 2023 alinity was reactive; in (b)(6) 2023 was nonreactive; in (b)(6) 2023 was reactive, another laboratory was negative for anti-hbc.Results provided: (b)(6) 2023 sid (b)(6) = 1.06 / 1.06 / 1.06 s/co.(b)(6) 2023 sid (b)(6) = 0.84 s/co.(b)(6) 2023 sid (b)(6) = 1.05 / 1.02 / 1.02 s/co.No impact to donor management was reported.
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Search Alerts/Recalls
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