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 use of positions 9 and 10 of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe. damage to the prep probe will render the instrument inoperative with the potential to delay reporting of results.