Catalog Number 300900 |
Device Problem
False Negative Result (1225)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2023 |
Event Type
malfunction
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Event Description
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Discrepant result for sars cov-2 target with the neumodx¿ flu a-b/rsv/sars-cov-2 vantage test strip.
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Manufacturer Narrative
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We are reporting this event in an abundance of caution and in accordance with the eua requirements.The ifu instructions for the neumodx¿ flu a-b/rsv/sars-cov-2 vantage test strip states: the results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.Positive results are indicative of active infection.Negative results do not preclude influenza virus, rsv, or sars-cov-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
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Manufacturer Narrative
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We are reporting this event in an abundance of caution and in accordance with the eua requirements.The ifu instructions for the neumodx¿ flu a-b/rsv/sars-cov-2 vantage test strip states: the results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.Positive results are indicative of active infection.Negative results do not preclude influenza virus, rsv, or sars-cov-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
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Event Description
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Discrepant result for sars cov-2 target with the neumodx¿ flu a-b/rsv/sars-cov-2 vantage test strip.
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Search Alerts/Recalls
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