Instrument data log files were reviewed by thermo fisher scientific.7500-series instrument: patient well gives a false positive call (1) due to inadequate centrifugation (trapped air bubble).Quant studio 12k instrument (off-label): files show late ms2 amplification, likely due to ms2 reagent handling and bubbles due to inadequate centriguration.Thermo fisher scientific's investigation of the patient results, run results, and additional data from the customer, concluded that the 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.
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Customer submitted 4 data files with several samples that did not appear to amplify (viral targets or ms2 control).Most were called as na by the interpretive software v1.2.However, there were a few samples that reported potentially false calls.Thermo fisher scientific's investigation of the patient results, run results, and additional data from the customer, concluded that the 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.After troubleshooting, the customer agreed to re-run the impacted assay plates; no potentially false results were reported to patients or their healthcare providers.The customer reported no patient deaths or serious injuries to thermo fisher scientific.
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