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 slide staining irregularities being experienced by some customers using beckman coulter dxh and lh slides with coulter trucolor stains and buffers. customers have reported stain irregularities with the use of the slides stains and buffers listed aboveincluding: - red blood cells that appear hypochromic refractile or punched out. - excess precipitate that may be interpreted as increased cellular granularity in white blood cells inclusions in red blood cells and/or particles that interfere with platelet estimates. - a dark blue/purple background stain that may interfere with the ability to read the slides.