A customer in (b)(6) notified biomérieux of obtaining irregular growth of candida albicans when testing clinical samples with the chromid® candida agar plate (ref.43631, lot 1007494920).The customer reported that the growth of candida albicans was normal on blood agar as compared to "no", "scanty", and "irregular shaped" colonies on the candida agar.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.
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A customer in (b)(6) notified biomérieux of obtaining irregular growth of candida albicans when testing clinical samples with the chromid® candida agar plate (ref.43631, lot 1007494920).In response to the customer complaint biomérieux conducted an internal investigation, which included testing of retained agar and a review of production records.Lot 1007494920 was past expiration and therefore could not be tested.Note: the customer did not submit the impacted strain for investigation therefore confirmatory testing of the isolate could not be performed.The following results were obtained: the retains of lots 1007462580 and 1007562620 were tested with atcc® organisms including candida albicans; all results were within specification review of the manufacturing batch records indicated that the impacted lot complied with specifications and neither non-conformances nor deviations were recorded.The error obtained by the customer was not reproduced.The chromid® candida agar plate package insert states: "growth depends on the requirements of each individual microorganism.It is therefore possible that certain yeast strains which have specific requirements (substrate, temperature, incubation conditions, etc.) may not develop or may not produce color." therefore, it is possible the impacted strain has specific growth requirements.However, as the impacted strains were not available for the investigation, it was not possible to verify this hypothesis.The investigation concluded chromid® candida agar plate lot 1007494920 is performing within specifications.
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