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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Siemens healthcare diagnostics has confirmed the potential for falsely elevated results with iron flex reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources. all lots of iron flex reagent cartridges have the potential for this issue.