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 low recovery values for reticulocytes may be generated from the unicel dxh 800 coulter cellular analysis system due to intermittent high electrical noise on the upper median angle light scatter (umal) produced by the volume conductivity scatter and multiple angle (vcsn) preamp board assembly part number (pn) b48187. the electrical noise produced by the vcsn preamp board assembly is greater than the instrument specification of 3.000 millivolt root mean square (mv rms).