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 confirmed that during sample processing under certain conditions the pk7300 does not always generate a reagent dispensing pressure error when the reagent vial becomes empty and no reagent is dispensed. sample processing will continue after a vial is empty only when the reagent alarm volume limit volume and associated mode shift alarm have not been set.