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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Leica received a complaint from a customer regarding bond rtu ttf-1 (product code pa0364) giving positive staining on thymoma tissue which was thought to be negative. the ttf-1 antigen had previously been characterised as staining thyroid and lung tumours only and this is the claim made on the instruction for use (ifu). our investigations following this complaint have demonstrated that ttf-1 has a wider expression than was originally thought.