The consumer reported conflicting results with the binaxnow covid-19 antigen self-test performed on (b)(6) 2024.The first test generated a negative result.The second test generated a positive result.Confirmation testing was not performed.Although requested, no additional patient information, including treatment and outcome, was provided.
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Fda udi : (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot: 228694 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 195-180/ lot: 228694 and test base part number 195-430wl/ 224821.The lot met the required release specifications.A review of the complaints reported false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 228694 showed that the complaint rate is 0.000358%.A review of the complaints reported false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot: 228694 showed that the complaint rate is 0.000179%.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.
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