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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Specific product codes and lot numbers of encor biopsy probes (vertical configuration) may have an incorrect sample trap assembly (lateral configuration). a portion of the affected lots contain units with incorrect sample trap assemblies affixed to the probe inside the product tray. the labeling on the outer product carton and inside packaging tray is correct. the incorrect sample trap assembly contains a shorter vacuum tubing and no clear tray cover.