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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Complaints related to optical degradation have increased on the dxh 800 and dxh 600 systems. customers have reported that they are experiencing an increase in one or more of the following: (1) flow cell clogs (2) ls offset errors during daily check or control analysis (3) high coefficients of variation for latron cp-x controls for low angle light scatter and/or axial light loss parameters (4) system messages and r-flagged results for nrbc diff and retic during control or patient analysis such as partial clogs (low event rated with diff rs) or a voltage failure (system event: d with diff rs).