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 02/09/2024 |
Event Type
malfunction
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Manufacturer Narrative
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D4 (b)(4).The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.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) 2024 using tests from the same lot on a nasal swab.The consumer stated the first test generated a positive result and the second test generated a negative result.No other testing was performed.No additional patient information, including treatment and outcome, was provided.
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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)(4) 2024 using tests from the same lot on a nasal swab.The consumer stated the first test generated a positive result and the second test generated a negative result.No other testing was performed.No additional patient information, including treatment and outcome, was provided.
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Manufacturer Narrative
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D4 udi: (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 223021 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 223021, test base part number 195-430wjr/ lot 220571.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 223021 showed that the complaint rate is (b)(4) respectively.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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Search Alerts/Recalls
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