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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Ortho clinical diagnostics received a customer complaint regarding the loss of calibration data following the installation of a development-only assay data disk (add) data release version (drv) 9241 or 9251 that was available in the on-screen mailbox on the main menu system status screen of their vitros 5600 integrated system.