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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Modification (mod) au2700-184 and au5400-190 were initiated by beckman coulter to replace the concentrated detergent tank b tubing with a more pliable material for easier insertion. beckman coulter has determined that the tubing/joint connection associated with these mods may leak concentrated detergent.