This report was initially submitted following notification that a customer in canada reported occasional misidentification of gram negative rods (e.G.Pseudomonas as burkholderia or acinetobacter as klebsiella) in association with the vitek® 2 gn id test kit.Biomérieux investigation was conducted.However, no patient strains, lab reports, raw data, lot # nor software version were provided by the customer.The customer reported testing the isolates from bbl chrom agar which is a non-recommended media.Testing from a non-recommended media may cause atypical reactions according to the vitek® 2 gn id knowledge base.A complaint history review was completed for these issues during the last 13 month timeframe with no implication of a trend.The most recent quarterly trend review did not identify this complaint as a systemic quality issue.Without the patient isolate(s) or raw data, no further investigational testing is possible.There is no evidence to suggest the vitek® 2 gn id test kit is performing outside of specifications.
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