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 that the intra-assay and inter-assay precision of the immulite/immulite 1000 and immulite immulite 2000 xpi anti-tg ab assays does not align with the representative data published in the instructions for use (ifu). siemens has conducted a "verification of precision performance" study to assess precision. while the concentrations did not exactly match those published in the ifu the study provides verification that the current precision performance is not in line with the ifu.