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 inc. (bec) has identified the following issue with the product listed in section a: the dxh 800 systems with software revision 2.0.0.1 transmits a fixed date/time field (december 30 1899) and an empty serial number field in the ret# string for 1)retic-x and 2) patient controls analyzed using "retic" as the test type.