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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Biomerieux cannot guarantee the characteristic coloration of the streptococcus b colonies at 24 hours and 48 hours of incubation. false negative results could lead to incorect diagnostic resulting to a serious deterioration in state of health of patients.