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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Bekcman coulter has received an increased number of service calls and customer complaints related to the hemoglobin (hgb) parameter on the act series analyzers. an investigation revealed that the issues may have been related to variability in a component of the diluents which in turn may lead to a film coating the inside of the wbc bath where the hgb is measured. the issue is not observed with all analyzers.