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 field safety notice to customers to emphasize that the prostate-specific antigen (psa) values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy. siemens is providing a limit of quantitation (loq) for the advia centaur psa assay at this time. the loq for psa on the advia centaur cp will follow.