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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Due to a labelling error some synchron systems multi calibrator diskettes (ref 442600 lot m002642g) may actually be thyroxine (t4) reagent calibrator diskettes. this issue only impacts synchron lx and dxc systems. this issue does not impact synchron cx systems.