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 02/26/2024 |
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 kit performed on (b)(6) 2024.The first test taken generated a positive result, and the second test, performed on the same day, generated a negative result.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: 229021a with internal positive quality control samples and negative quality control swabs.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 195-160/ lot: 229021a, test base part number 195-430wjr/ lot: 225026.One false positive result was observed during quality control release testing which is acceptable according to release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot: 229021a 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: 229021a showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.
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