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 03/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.A supplemental report will be provided after completion.Device discarded, single use.
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Event Description
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The consumer reported a conflicting result with binaxnow covid-19 ag self-test on (b)(6) 2023.The consumer received a positive result, and a negative result on (b)(6) 2023.No additional patient information, including treatment and outcome, was provided.
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Manufacturer Narrative
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Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 200198 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 200198 and device part number 195-430h/ lot 196044.The lot met the required release specifications.(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 issues including the self-test user performance, interpretation of the result, or the specific patient sample.Based on the above summary, the investigation is deemed complete.Abbott diagnostics scarborough will continue to monitor and trend for this reported issue as part of our ongoing post market surveillance.H3 other text : device discarded, single use.
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Event Description
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The consumer reported a conflicting result with binaxnow covid-19 ag self-test on (b)(6) 2023.The consumer received a positive result, and a negative result on (b)(6) 2023.No additional patient information, including treatment and outcome, was provided.
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Search Alerts/Recalls
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