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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Siemens has received customer complaints that the lyophilized cake is not fully dissolved after the stated time in the mmb calibrator instructions for use (ifu). the frequency of this occurrence is low but if it occurs gel-like clumps may be observed.