D4 udi: (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 224703 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 224703, test base part number 195-430h / lot 220044.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 224703 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.H3 other text : single-use, device discarded.
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The consumer reported a false positive result with the binaxnow covid-19 antigen self test performed on (b)(6) 2024.Additional testing was performed on the (b)(6) 2024 with a different brand test (platform - unknown) which generated a negative result.The consumer stated that they have used expired kit of different brand test.No additional patient information, including treatment and outcome, was provided.
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