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 determined that there is a potential for incorrect settings to be installed on north american ichemvelocity urine chemistry analyzers. - the installation of international settings can result in the generation of erroneous false low results for some of the analytes at some concentrations. - the installation of colors different from those stated in the instructions for use (colorless straw yellow amber red blue) for output settings will result in incorrect reporting of colors. for example if green is the color choice for the output setting instead of blue green will be reported.