A customer in the united states notified biomérieux of out of range low results for internal quality control (qc) strain candida albicans (atcc 90028) in association with etest® itraconazole (reference (b)(4)).An mic value of 0.032 g/ml was obtained for an expected mic value range of 0.064-0.25 g/ml.An internal biomérieux investigation was performed.Retained sample analysis: the conformity of the lot reported, 1005507630, and a reference lot 1005871860 used during the investigation, were confirmed with the atcc quality control strains tested for the release of this reference: atcc (b)(6) candida parapsilosis, atcc (b)(6) candida krusei, atcc (b)(6) candida albicans.Complaints trend analysis: no other complaint was registered on this lot.The trend analysis was reviewed and did not indicate any issues with this product.Conclusion: the results obtained with the atcc quality control strains tested during this investigation conformed with the product specifications.No other complaints were registered on this lot number and the trend analysis of the complaints does not show any problem on this reference.No further actions were deemed necessary.
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