A customer in (b)(6) reported a misidentification of corynebacterium macginleyi from a patient isolate (eye sore), as proponobacterium acnes in association with the vitek® 2 anc test kit 20cards (lot 2440440103).The customer stated that while testing a gram positive bacillus strain from the patient isolate on cos and can media, a growth was observed that suggested a potential corynebacterium species.The customer tested the strain on the anc card, and an identification of proponobacterium acnes (95%) was obtained.The customer sent the strain to the national reference center for testing and the result was corynebacterium macginleyi by mass spectrometry.No incorrect result was reported to the clinician, but there was a 48 hour delay in reporting results due to complementary testing.Corynebacterium macginleyi species is not a claimed species for vitek 2 anc cards.A biomérieux internal investigation will be initiated.
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