Catalog Number 09203079190 |
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 02/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product labeling states: "the sensitivity of the elecsys anti-sars-cov-2 assay early after infection is unknown.Negative results do not preclude acute sars-cov-2 infection.If acute infection is suspected, direct testing for sars-cov-2 is necessary." the investigation is ongoing.
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Event Description
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The initial reporter complained of a questionable negative result for 1 patient tested for elecsys anti-sars-cov-2 (anti-sars-cov-2) on a cobas e 801 analytical unit with serial number (b)(4).The questionable result was reported outside of the laboratory.(b)(6).
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Manufacturer Narrative
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Section d4, expiration date was updated.The investigation determined that the elecsys anti-sars-cov-2 results were as expected.Product labeling states: "a negative test result does not completely rule out the possibility of an infection with sars-cov-2.Serum or plasma samples from the very early (pre-seroconversion) phase can yield negative findings.Therefore, this test cannot be used to diagnose an acute infection.Also, over time, titers may decline and eventually become negative." the investigation did not identify a product problem.
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Search Alerts/Recalls
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