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 confirmed an issue where the red blood cell (rbc) aperture baths can contain residue in the sweep flow fittings. this residue may potentially create increased background failures flagged results and vote outs for rbc and platelet (plt) parameters.