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 reports a performance issue related to specific lots of lysercell wdf reagent used on xn and xn-l series instruments. when using the affected lots some customers have experienced an increase in false positive differential flags on patient samples. reportable results from the instrument were not affected.