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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Beckman coulter has identified that the unicel dxc synchron clinical systems - bunm/uream electrode kit may contain ferrite beads that are difficult to attach to the electrode. additionally there are no electrode installation instructions in the unicel dxc clinical system ifu or in the bunm/uream electrode kit.