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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The manufacturer has identified during an internal investigation on a unique customer complaint that a change in the cobas c701-702 application prozone limit check was required fo the triglycerides assay to address a potential for low results without the expected flag. the application package has been modified and has been provided accordingly to add the new prozone limit check.