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 06/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 two binaxnow covid-19 antigen self tests performed on (b)(6) 2023.The result from the first test was negative.The repeat test generated a positive result.Although requested, 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 two binaxnow covid-19 antigen self tests performed on (b)(6) 2023.The result from the first test was negative.The repeat test generated a positive result.Although requested, 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 206600 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 206600, test base part number 195-430h/ lot 201874.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 206600 showed that the complaint rate is (b)(4) respectively.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue; however, it could possibly be related to the specific patient sample.D4 expiration date h3 other text : single-use, device discarded.
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Search Alerts/Recalls
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