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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During the manufacture of liasion analyzers two dilutor syringes malfunctioned. the glass body of the syringe became detached from the metal collar. the defect does not affect all dilutor syringes and all reported failures in the field have occurred within a week after installation during routine use.