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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Genzyme diagnostics has determined that there was a label error for the cholesterol assay kit. the labels on the kit components for lot 37772 were reversed. colour reagent (r1) label was on the phenol reagent and phenol reagent (r2) label was on the colour reagent. label error will not affect test results as long as components of this lot are not interchanged with components from other lots.