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 has identified a software anomaly when using ortho provue software version 3.1. internal testing has revealed that the analyzer did not dispense plasma following a cancelled microtube due to an error that occurred during pipetting. when this occurred the analyzer did not generate a card volume error as expected which allowed potentially erroneous test results to be reported.