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 paklx instructions for use (ifu) version 303285.Ifuen rev k and the matchit! platelet antibody software database were not aligned. the ifu states that a minimum of 60 events must be collected per bead region. the matchit! platelet antibody software database requires a minimum of 100 events per bead region. this discrepancy caused invalid results when using the matchit! platelet antibody software to analyze a bead.