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 that under a rare set of conditions when utilizing the routine inventory screen to enter a user defined method (empty) flex the system may assign the user defined method flex to a different flex that is currently in inventory on the system and then use the incorrect flex cartridge to process the user defined method. investigation of the issue has determined that this error will only occur if the assign empty reagent cartridge window has been left open and the flex inventory on the system changes.