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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Sample analysis cycle time for specimen with high white blood cell (wbc) counts (approximately 45.0 x 103 /ul or higher) is approximately two (2) minutes longer than expected for the dxh analytical systems with the software revisions unicel dxh 800 coulter cellular analysis system software revision 2.0.2.1 and unicel dxh 600 coulter cellular analysis system software revision 1.0. the original total sample analysis cycle time (analysis and cleaning cycle) was approximately two and a half (2 1/2) minutes while the current cycle time is approximately five and a half (5 1/2) minutes. test results are not affected by this issue.