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 japan (scj) determined that some xn-series analyzers had the wiring for the feeder assembly #113 improperly routed potentially causing contact with moving parts of the tube sampling mechanism. contact with the piercer up/down mechanism can cause abrasion of the wire's coating and a short circuit of the tube sampling mechanism.