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 has confirmed that immulite systems anti-tg ab calibration verification material (cvm) lot 102 levels cvm2 through cvm4 catalog ltgcvm is recovering high outside of the published +/- 2sd guideline ranges in the ifu. this issue applies to use with the immulite 2000 and immulite 2000 xpi anti-tg ab assay only.