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 confirmed the following issue with the software version 4.3. being used in the unicel dxi 600 and dxi 800 access immunoassay systems. if a laboratory changed a default sample type setting on the tests screen while running unicel dxi system software version 4.3 the new setting would not be saved to the system database. the changed sample type setting would reset to the previously saved setting when power was interrupted to the system or if an operator rebooted the system.