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 10/10/2022 |
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.Device discarded, single use.
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Event Description
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The consumer reported false negative results with the binaxnow covid-19 antigen self-test performed in (b)(6) 2022.This mfr.Report addresses test one (1) of two (2).The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed early in month of (b)(6) 2022.The exact test date was not provided.Additional testing was performed several days later using another brand of rapid antigen test that generated a positive result.The consumer stated that they were exposed to covid-19 the week prior to testing and reportedly quarantined.No additional patient information, including treatment and outcome, was provided.
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Manufacturer Narrative
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The customer was unable to provide the required information.The 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.H3 other text : device discarded, single use.
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Event Description
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The consumer reported false negative results with the binaxnow covid-19 antigen self-test performed in oct2022.This mfr.Report addresses test one (1) of two (2).The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed early in month of oct2022.The exact test date was not provided.Additional testing was performed several days later using another brand (quickvue) of rapid antigen test that generated a positive result.The consumer stated that they were exposed to covid-19 the week prior to testing and reportedly quarantined.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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