Catalog Number 195-160 |
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 02/28/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.
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Event Description
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The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on (b)(6) 2024 using a nasal sample.Initial testing was performed on the same day via a flowflex rapid antigen test which generated a positive result.Additional testing was performed on the same day via a flowflex rapid antigen test and a quick view rapid antigen test, both generating negative results.The consumer indicated they were asymptomatic.The consumer confirmed there was no harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in treatment.
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Manufacturer Narrative
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The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend / unexpected performance at the lot and product family level.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.
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Event Description
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The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on (b)(6) 2024 using a nasal sample.Initial testing was performed on the same day via a flowflex rapid antigen test which generated a positive result.Additional testing was performed on the same day via a flowflex rapid antigen test and a quick view rapid antigen test, both generating negative results.The consumer indicated they were asymptomatic.The consumer confirmed there was no harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in treatment.
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Search Alerts/Recalls
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