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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There is a potential contamination of the cuvettes of the cobas u cuvette which may lead to false positive result for the parameter bacteria (bac) on the cobas u701 microscopy analyzer. only lot 16483701 is affected by this issue.