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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If the abl90 flex analyzer is tilted it may cause a negative bias on sodium results up to 7% (minus 10mm). this issue has been reported when the analyzer has been installed on a roll stand and tilted (i.E. the support plate is not horizontal).