A customer in (b)(6) notified biomérieux of obtaining false susceptible fluconazole results for candida glabrata in association with the etest® fluconazole fl 256 ww s30 (ref 412350, lot 1008297750).The customer reported observing the same issue with eight (8) patient samples.The customer performed analysis with both broth microdilution (bmd) and etest® fluconazole fl 256 ww s30.Bmd = fluconazole resistant etest = fluconazole susceptible there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.Note: etest® fluconazole fl 256 ww s30 (ref 412350) is not registered for use in the united states.However a similar product, etest® fluconazole fl 256 us s30 (ref 412349), is registered for use in the united states (k040560).
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