This report was initially submitted following notification from a customer in the united states regarding false positive cefoxitin screen results for a staphylococcus aureus isolate in association with the vitek® 2 ast-gp78 test kit (ref.421051, lot 2781427403) and software version 9.02.The customer did not save the isolate; therefore, no investigational testing could be performed.Submittal of the isolate is required in order to confirm a vitek® 2 discrepancy compared to the reference method.Vitek® 2 ast-gp78 lot 2781427403 met final qc release criteria, and passed qc performance testing.See section h10.
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