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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Following internal investigation the manufacturer identified a situation where the specifications for qc recoveries could not be fulfilled for the sensitive applications (urien-csf) for the tina-quant igg gen-2 assay (cat #05220718190 lot 26358701) on cobas c701-702 analyzers. this situation has no impact in canada since the identified lot will not be distributed to users.