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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Complaints received regarding substrate l2subx lots 253 and 254 which may affect the performance of the immulite 2000 and immulite 2500 assays. these substrate lots may introduce a shift in both quality control and patient results.