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 a positive bias with the bio-rad lyphochek tumor marker plus control and the bio-rad liquichek tumor marker control when used with immulite 2000/immulite 2000 xpi gi-ma (ca19-9) assay kit lots 312 and 313. in addition a greater than expected change in patient sample recovery may be observed when moving from kit lot 311 to kit lots 312 and above. while recovery with patient samples for individual kit lots continues to meet siemens quality control release specification kit lot 311 was observed to perform at the lower end of the specification and kit lot 312 at the upper end of the specification resulting in a greater than expected difference between these two kit lots.