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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The manufacturer has identified during an internal investigation and changed labelling recommendations that a change was required in the icteric index (i-index) claim of the alkaline phosphatase (alp2) assay on the cobas integra plateform.