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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Reason for recall: a packaging error resulted so the ifu for dako product ir 062 (flex monoclonal mouse anti - human cd15) was found in the product instead of the ifu for flex monoclonal mouse anti-human cdx2.