Additional data: h10: testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 177935 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 7d2648/ lot 177935 and test base part number 10732998 / lot 169496.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 177935 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.However a possible assignable root cause is sample interference or cross contamination.
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