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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A product defect named "lip-out" was detected for bd vacutainer pst tubes. it consists of gaps of various sizes in the structure of the tube wall that is present at the lip of the tube. these gaps are covered by the stopper and hemogard closure so the tube can be evacuated and used for blood collection. customer complaints cite jamming of preanalytical automation (tube decappers) and leakage of blood in the specimen transport bag.