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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Iris international has become aware of an issue in which permature degradation of bilirubin for specific lots may lead to bilirubin control failures for the irispec ca bilirubin control material. the irispec ca control may fail for the bilirubin analyte. the laboratory will be unable to process patient samples until qc passes. not all bottles within a specific lot may be affected.