A customer from (b)(6) reported to biomérieux a misidentification of two campylobacter jejuni strains (atcc 33560 lots 111-38-1, 111-40-2) as campylobacter coli in association with the vitek® 2 nh test kit (udi (b)(4)).The customer tested the strains at 24 and 48 hours immediately after incubation.The results obtained were campylobacter coli (94%, 96%, 99%) and low discrimination.The conforming quality control id was eikenella corrodens.There was no patient involvement as the customer was performing a control test for campylobacter strains.A biomérieux internal investigation will be initiated.
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This report was initially submitted following notification that a customer in (b)(6) contacted biomérieux to report a misidentification of campylobacter jejuni ssp jejuni atcc® 33560¿ as campylobacter coli in association with the vitek® 2 neisseria-haemophilus (nh) identification (id) test kit.Investigational testing was performed using two atcc® 33560¿ strains (s1 and s2) submitted by the customer, as well as the internal biomérieux atcc® 33560¿ strain (s3).It should be noted that this atcc® strain is not a qc strain intended for the nh id card.Investigational testing included: vitek® ms: obtained identification to campylobacter jejuni for all three atcc® strains.Vitek® 2 nh id (customer lot 2450204203): s1 - low discrimination between c.Coli and c.Jejuni ssp jejuni.S2 - low discrimination between c.Coli and c.Jejuni ssp jejuni.S3 - very good identification to campylobacter coli.Vitek® 2 nh id (random lot 245398920): s1 - excellent identification to campylobacter coli.S2 - low discrimination between c.Coli, c.Jejuni ssp jejuni and c.Fetus ssp fetus.S3 - excellent identification to campylobacter coli.The investigation reproduced the customer results 50% of the time.The investigation concluded campylobacter jejuni ssp jejuni atcc® 33560¿ is an atypical strain for testing via the vitek® 2 nh id card.As previously noted, this atcc® strain is not a qc strain intended for the nh id card.
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