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 determined that when reporting units are not configured in us-1 and a delta check limit is set up using a difference value the unicel dxh 800 and unicel dxh 600 system manager may under or over generate delta check flags. the issue does not apply to delta checks configured using percent difference limits. delta checks performed at the laboratory information system (lis) are not affected. patient results are not affected.