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 products has confirmed that the mentioned enzygnost anti-vzv/igg lots can show a higher variation in homogeneity. this can lead to invalid runs by not meeting the run validation criterion for the reference p/n at the start and end of a series.