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 03/23/2024 |
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.
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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 on an unknown sample type.Additional testing was performed at an urgent care on (b)(6) 2024 via an unknown method which generated a positive result.The consumer indicated they were symptomatic.No additional information, including treatment and outcome, was provided.
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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 on an unknown sample type.Additional testing was performed at an urgent care on (b)(6) 2024 via an unknown method which generated a positive result.The consumer indicated they were symptomatic.No additional information, including treatment and outcome, was provided.
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Search Alerts/Recalls
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