(b)(6) contacted thermo fisher scientific regarding 3 potential false positive results obtained using the taqpath covid-19 combo kit test.Customer cited a dip in flourescence in the multicomponent plot.Results were presumed to be false positive because: accession # (b)(6) went from positive on (b)(6) 2020 p4 to inconclusive on (b)(6) 2020 p1.Accession # (b)(6) went from positive on (b)(6) 2020 p6 to not detected (negative) on (b)(6) 2020 p1.Accession # (b)(6) went from positive on (b)(6)2020 p5 to not detected (negative) on (b)(6) 2020 p2.It is unknown if false results were reported to healthcare providers or patients because the customer was not responsive to 3 follow-up attempts to obtain additional details.Thermo fisher scientific's investigation of the patient results, run results, and additional data from the customer concluded that the late amplification and false positive results were due to user error.Specifically, the user did not properly vortex and/or centrifuge the qpcr plate according to ifu instructions and provided training materials.The customer reported no patient death or serious injury to thermo fisher scientific.
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