A customer in the united states notified biomérieux of a misidentification result for streptococcus constellatus in association with vitek® 2 gp id test kit (ref 21342), lot 2420407203.Vitek 2 identified cap survey strain d17 as kocuria rosea twice.The intended result was streptococcus constellatus.As there was no patient directly associated with the cap survey strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
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An internal biomérieux investigation was performed with results as follows: the biomérieux internal cap d-17 swab was re-hydrated and subcultured to remel tsab agar.Testing included individual organism suspensions with gp cards from three (3) different card lots as well as the vitek® ms instrument.The gp cards resulted in excellent identification of s.Constellatus on one (1) card, and low discrimination s.Constellatus / s, agalactiae on five (5) cards.The vitek® ms instrument confirmed the isolate as s.Constellatus with a 99.9% confidence value.Vitek® 2 gp cards are performing as expected.A review of the customer's kocuria rosea reactions demonstrated thirteen (13) atypical negative reactions (adh1, aglu, tyra, polyb, dgal, nag, dmal, dmne, 0129r, sal, sac, dtre, opto) and one (1) atypical positive reaction (amy) for an identification of s.Constellatus according to the gp knowledge base.An increased number of atypical reactions can indicate contamination, mixed culture, compromised viability of the strain, use of non-recommended media or other user set up errors or an atypical strain.
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