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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There are sudden failures of the di-60 home position sensors that cause multiple error messages and prevents operation of the system. the home position sensors enable the analyzer to recognize proper positioning of the slides the camera and optics to scan and locate cells on a stained blood smear. failure of any one of the sensors disables the analyzer.