A customer from (b)(6) has notified biomérieux of obtaining a misidentification of lelliottia amnigena (enterobacter amnigenus) as pantoea while testing an aglae proficiency sample with the api® 20 e 25strips (ref 20100, lot 1007955490).Maldi-tof testing was performed as an alternative method and obtained an identification of lelliottia amnigena.Global customer service (gcs) confirmed that lelliottia amnigena is known as enterobacter amnigenus in the api® technical library and can be identified by api® 20 e strips.Gcs reviewed the data provided by the customer and identified that the customer obtained several atypical negative test results and an atypical positive result for an identification of lelliottia amnigena.As this was an aglae proficiency sample, there is no patient involved.A biomérieux internal investigation has been initiated.
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This report was initially submitted following notification from a customer in france regarding a misidentification of lelliottia amnigena (enterobacter amnigenus) as pantoea while testing an algae proficiency sample with the api® 20 e 25strips (ref 20100, lot 1007955490).The review of production and quality control data for batch 1007955490 did not indicate any defects or anomalies which could explain the misidentification of the enterobacter amnigenus germ as pantoea spp.The tests performed on biomerieux¿s sample library of batch 1007955490 complied with specifications, and with the data obtained during the release of the batch.The tests performed on the customer¿s strain did not confirm the customer's identification of pantoea spp.The expected identification of enterobacter amnigenus was obtained.The misidentification to pantoea spp obtained by the customer was not reproduced internally.The customer¿s issue was not confirmed; therefore, no preventive or corrective action is necessary.
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