This report is being submitted to provide the initial report and investigation conclusion.Testing was performed at abbott diagnostics (b)(4), inc.On retained kit lot 187871 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 187871 and device part number 195-430h / lot 184143.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 187871 showed that the complaint rate is (b)(4).In conclusion, abbott diagnostics (b)(4) was unable to determine the exact root cause of the reported issue; however, it could possibly be related to issues including the self-test user performance, interpretation of the result, or the specific patient sample.Please reference mfr report numbers: 1221359-2022-04315, and 1221359-2022-04336 - 1221359-2022-04338.
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The costumer reported four(4) false negative patient result with the binax now covid-19 antigen self-test performed on multiple dates throughout the first week of (b)(6) 2022.This mfr.Report addresses patient result four (4) of four (4).The consumer reported a false negative result with the binax now covid-19 antigen self-test performed on (b)(6) 2022 using a kitted nasal swab sample that generated a negative result.Confirmation pcr testing was performed on (b)(6) 2022 at a local pharmacy that generated a positive result.No additional patient information, including treatment and outcome, was provided.
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