ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
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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 01/27/2024 |
Event Type
malfunction
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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 conflicting results with the binaxnow covid-19 antigen self-test kit performed on or before (b)(6) 2024.The first test taken generated a negative result, and the second test, performed on the same day, generated a positive result.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 kit performed on or before (b)(6) 2024.The first test taken generated a negative result, and the second test, performed on the same day, generated a positive result.No additional patient 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) testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 205529 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: 205529, test base part number 195-430h/ lot: 200975.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 205529 showed that the complaint rate is(b)(4).A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 205529 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.H3 other text : single use; device discarded.
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