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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Beckman coulter has observed an intermittent increase in access system "wash carousel motion errors" with specific lots of access system reaction vessels (rvs). if the system is experiencing these errors the errors will be documented in the event log and the system will be in the not ready mode. access/access 2 immunoassay systems synchron lxi 725 clinical system and/or unicel dxc 600i synchron access clinical system are impacted.