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 over-recovery of samples with concentrations greater than 5.5 ng/ml. siemens has determined that these lots are linear up to a concentration of 5.5 ng/ml instead of 10 ng/ml as stated in the instructions for use (ifu). quality control materials at concentrations between 5.5 and 10 ng/ml will detect this issue.