Biomérieux investigation was conducted.The customer's (b)(6) strain was not submitted, so the internal lyophilized (b)(6) sample was reconstituted and tested.The reconstituted sample was subcultured, and vitek® 2 gp id testing included two cards from the customer lot and two cards each from three random lots (total of eight cards).Excellent identification of pediococcus acidilactici were obtained on four cards from random lots.The two cards from the customer's lot and two cards from random lots resulted in low discrimination calls of pediococcus acidilactici/pediococcus pentosaceus.The low discrimination identification results are acceptable since they include the expected result of pediococcus acidilactici.These species are closely related and review of the expected data for pediococcus acidilactici demonstrated no atypical reactions.The investigation concluded the vitek® 2 gp id is performing as expected.Device not returned to manufacturer.
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