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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Under certain circumstances when patient birth date manually entered in a specific field of the cobas it 1000 version 2.00.0x and newer its application may save an earlier date instead. there could be critical risk associated to newborns and infant's wrong patient birth dates since a different assay validation range could be used.