Catalog Number 195-160 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2023 |
Event Type
malfunction
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Event Description
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The consumer reported conflicting results with a binaxnow covid-19 antigen self-test performed on (b)(6) 2023 on a nasal sample.The first test generated a positive result.Repeat testing was performed on the same day on another binaxnow covid-19 antigen self-test on a nasal sample and generated a negative result.Confirmation testing was not performed.The consumer was symptomatic.The consumer confirmed there was no patient harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in their treatment.
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Manufacturer Narrative
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Fda udi ¿ (b)(4).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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Manufacturer Narrative
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Fda udi ¿ (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 210826 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 195-160 / lot 210826 and device part number 195-430h / lot 206074.The lot met the required release specifications.(b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however it could have possibly been related to the specific patient sample.H3 other text : single use; device discarded.
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Event Description
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The consumer reported conflicting results with a binaxnow covid-19 antigen self-test performed on (b)(6) 2023 on a nasal sample.The first test generated a positive result.Repeat testing was performed on the same day on another binaxnow covid-19 antigen self-test on a nasal sample and generated a negative result.Confirmation testing was not performed.The consumer was symptomatic.The consumer confirmed there was no patient harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in their treatment.
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Search Alerts/Recalls
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