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 04/01/2023 |
Event Type
malfunction
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Event Description
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The consumer reported conflicting results with the binaxnow covid-19 antigen self-test performed on (b)(6) 2023.The consumer initially tested positive with the binaxnow covid-19 antigen self-test.The consumer performed a repeat test with another binaxnow covid-19 antigen self-test ninety (90) minutes later which generated a negative result.The consumer was symptomatic.No additional information, including treatment and outcome, was provided.
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Manufacturer Narrative
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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 conflicting results with the binaxnow covid-19 antigen self-test performed on (b)(6) 2023.The consumer initially tested positive with the binaxnow covid-19 antigen self-test.The consumer performed a repeat test with another binaxnow covid-19 antigen self-test ninety (90) minutes later which generated a negative result.The consumer was symptomatic.No additional information, including treatment and outcome, was provided.
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Manufacturer Narrative
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Investigation conclusion: testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 197039 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 197039, test base part number 195-430h / lot 184649.The lot met the required release specifications.A review of the complaints reported as false positive and false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 197039 showed that the complaint rate is (b)(4), respectively.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, it could possibly be related to issues including the self-test user performance, interpretation of the result, or 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 the binaxnow covid-19 antigen self-test performed on (b)(6) 2023.The consumer initially tested positive with the binaxnow covid-19 antigen self-test.The consumer performed a repeat test with another binaxnow covid-19 antigen self-test ninety (90) minutes later which generated a negative result.The consumer was symptomatic.No additional information, including treatment and outcome, was provided.
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Manufacturer Narrative
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The investigation remains in progress.A supplemental report will be provided after completion.Correction: h6 - health effect impact code h3 other text : single use; device discarded.
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Search Alerts/Recalls
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