ABBOTT GMBH ALINITY S ANTI-HBC REAGENT KIT; HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)
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Catalog Number 06P06-60 |
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 02/24/2023 |
Event Type
malfunction
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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.Patient identifier sids: (b)(6).
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Event Description
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The customer reported false nonreactive alinity s anti-hbc results on two donors.Results provided: (b)(6) = 0.98 s/co; another laboratory¿s alinity s = 1.08 / 1.14 / 1.12 s/co, nat negative.(b)(6) = 0.91 s/co, another laboratory¿s alinity s = 1.07 / 1.06 / 1.08 s/co, nat negative.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.
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Event Description
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The customer reported false nonreactive alinity s anti-hbc results on two donors.Results provided:
(b)(6) = 0.98 s/co; another laboratory¿s alinity s = 1.08 / 1.14 / 1.12 s/co, nat negative.(b)(6)= 0.91 s/co, another laboratory¿s alinity s = 1.07 / 1.06 / 1.08 s/co, nat negative.No impact to donor management was reported.
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