D4-udi:(b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 203486 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: 203486, test base part number 195-430h/ lot: 197252.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 203486 showed that the complaint rate is (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 the specific patient sample.H3 other text : single use; device discarded.
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The consumer reported false negative results with the binaxnow covid-19 antigen self-test kit for two (2) tests performed on various dates.This mfr.Report addresses test two (2) of two (2).The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on (b)(6) 2024 on an unknown sample type.Initial testing was performed on (b)(6) 2024 using a binaxnow covid-19 antigen self-test which generated a negative result.Additional testing was performed at the doctor¿s office on (b)(6) 2024 via an unknown brand of rapid antigen test which generated a positive result on a nasal sample.No additional information, including treatment and outcome, was provided.
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