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 high and/or out-of-range values for total nucleated cells (tnc) on control level 1... when compared to the published table of expected results. the issue was initially reported in april 2015 by a united states customer. there has been no report of death or injury related to this issue.