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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Customer reports have indicated occurences of atypical negatve o129r reactions for enterococcus casseliflavus atcc 700327 in association with vitek 2 gp id causing failure of the quality control testing. the expected o129r reaction for atcc 700327 strain is positive.