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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Beckman coulter has identified an issue with editing or amending of results at the dxh system manager in the unicel dxh 800 and 600 coulter cellular analysis systems. cbc (complete blood count) results edited or amended at the system manager may cause dependent calculated results which originally displayed a non-numeric code such as "-----" to display erroneous results in place of the non-numeric code.