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 become aware of reports of erroneously low modular glucose (glucm) results from users of unicel dxc and synchron lx instruments (synchron lx20 lx20 pro lxi 725 unicel dxc 600 unicel dxc 600 pro unicel dxc 600i unicel dxc 800 unicel dxc 800 pro unicel dxc 880i unicel dxc 680i unicel dxc 660i unicel dxc860i).