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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Sysmex corporation has informed siemens healthcare diagnostics products gmbh about a phenomenon affecting ca series systems. under rare circumstances there is a potential the system might fail to alert the operator about an individual sample id no. assigned to multiple patient measurement results when using the built-in barcode scanner. under very rare circumstances this may lead to an incorrect diagnostic and patient treatment decision due to potential of a mismatched result for the patient.