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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Dimension vista software version 3.4 for below manufacturer assay range erroneously flags patient test results that that are within the assay range as defined in the instructions for use for the respective method. this issue is isolated to vista software version 3.4. customers who have not made any changes to the default method configurations.