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 09/14/2023 |
Event Type
malfunction
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Event Description
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The consumer reported a conflicting result with the binaxnow covid-19 antigen self-test performed on (b)(6) 2023.Per the consumer, the first test taken generated a positive result and the second test conducted the same day generated negative result.Confirmation testing was not performed.Additionally, the consumer performed a binaxnow covid-19 ag self test on (b)(6) 2023 and 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).The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.H3 other text : single-use, device discarded.
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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 218885 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 218885, test base part number 195-430h / lot 216186.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 218885 showed that the complaint rate is (b)(4) respectively.Abbott diagnostics scarborough 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.H3 other text : single-use, device discarded.
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Event Description
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The consumer reported a conflicting result with the binaxnow covid-19 antigen self-test performed on (b)(6) 2023.Per the consumer, the first test taken generated a positive result and the second test conducted the same day generated negative result.Confirmation testing was not performed.Additionally, the consumer performed a binaxnow covid-19 ag self test on (b)(6) 2023 and generated a negative result.No additional patient information, including treatment and outcome, was provided.
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Search Alerts/Recalls
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