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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The ca-1500 series can develop micro holes by mechanical wear in the curved part of the sample arm tubing. the mechanical damage could be the result of a gradual wear out process especially on systems with a high workload or they might occur if the installation during a tube exchange is executed without a specific orientation of the tube bending and the appropriate fitting to the mechanics of the ca-1500 analyzer.