Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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An analysis was performed on the essential agreement rate reflecting the mic result obtained by the product for a significant strains kit including enterobacteriaceae haemophilus and s. pneumoniae. species. then an additional analysis was done on the clinical categorization of the strains based on clsi guidance. the following have been identified: the investigation confirmed a potential performance issue on strains categorization for streptococcus pneumoniae and for enterobacteriaceae strains limited to oral cefuroxim breakpoints and based on 2016 clsi clinical standards only. for streptococcus pneumoniae on etest? xm256 (cefuroxime) foam and spb that could lead to minor error on clinical strains :false susceptible result instead of intermediate results with bmd (broth micro dilution) reference method. false intermediate result instead of resistant results with bmd reference method _ for enterobacteriaceae on etest? xm256 (cefuroxime) foam and spb that could lead to minor error on clinical strains: false susceptible result instead of intermediate results with ad (agar dilution) reference method. false intermediate result instead of resistant results with ad reference method products perform within the specification when using the 2016 eucast guidelines.