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 01/01/2024 |
Event Type
malfunction
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Event Description
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The consumer reported false negative results with the binaxnow covid-19 antigen self-test kit for four (4) tests performed on two (2) patients on an unknown date.This mfr.Report addresses test four (4) of four (4).The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on an unknown date on an unknown sample type.Additional testing was performed twice on the same day using an indicaid rapid antigen test and a flow flex rapid antigen test which generated positive results each respectively.No additional information, including treatment and outcome, was provided.
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Manufacturer Narrative
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B3: the date provided is an approximation as the exact event date was not provided.D4-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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Event Description
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The consumer reported false negative results with the binaxnow covid-19 antigen self-test kit for four (4) tests performed on two (2) patients on an unknown date.This mfr.Report addresses test four (4) of four (4).The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on an unknown date on an unknown sample type.Additional testing was performed twice on the same day using an indicaid rapid antigen test and a flow flex rapid antigen test which generated positive results each respectively.No additional information, including treatment and outcome, was provided.
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Manufacturer Narrative
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B3: the date provided is an approximation as the exact event date was not provided.D4-udi:(b)(6) testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 225161 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: 225161, test base part number 195-430h/ lot: 221919.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 225161 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, it could have possibly been related to patient sample.H3 other text : single use; device discarded.
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Search Alerts/Recalls
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