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 the silkscreen label on the left leg/panel of the fp1000 cell preparation system at a customer site incorrectly identifies the fuse rating associated with the two fuses located on that panel. the rating is shown as 100a instead of 6.0a on the label.