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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Occurence of misadjustmenet of the iswap (automated plate handler) component of the cobas 4800/cobas x480 sample preparation module. this situation could be linked to a possible cross contamination during sample preparation.