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 trend of increasing adjustment slopes on immulite 2000/2000xpi erythropoietin and immulite 2500 erythropoietin as kits age has been observed. this leads to slopes >1.8 and failed adjustments within the shelf life of the kits. no impact on qc or patient samples has been observed with the increasing adjustment slopes.