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 is issuing a communication to advise that some patient samples exhibit sample specific dilution over-recovery outside of the representative dilution recovery data provided in the advia centaur ca 125ii assay instruction for use. investigations performed by siemens healthcare diagnostics demonstrated dilution recoveries up to 140% with certain patient samples. studies indicate the dilution over-recovery is patient sample specific. the advia centaur ca 125ii assay instruction for use will be updated to include a statement refering to the potential for sample specific non-linear dilution. the performance of the advia centaur ca 125ii assay has not changed.