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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The manufacturer has confirmed that a limited number of units from specific product code / lot number combinations of the encor biopsy probes may have packaging damage resulting from transportation. the packaging damage ranges from broken trays to visual cosmetic defects of the trays.