On (b)(6) 2015, a customer contacted biomerieux to report a discrepant results when using product lyfocults plus candida krusei during an internal quality control test.The customer stated the mic, minimum inhibitory concentration range, of the amphotericina b was:<0,25 and the expected range was 0,50< 2.00.The customer stated that retesting was performed on the subject strain using two different vitek 2 systems; anomalies were noted on both systems qc results.There are no issues with other strains of candida species or testing process; operated correctly all stages of sample preparation including controls on sterility.No patient results were affected or delayed results reported.
|