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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Randox has confirmed that acth in their immunoassay premium plus quality control and immunoassay premium quality control does not meet the quoted reconsituted stability claim in the product ifu. they now recommend that acth is to be assayed immediately after the 30-minute reconstitution procedure.