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 (ocd) has determined that some dilution factors configured on the engen laboratory automation system are not supported in the instructions for use for the following 4 ocd vitros products: vitros che slides vitros crbm slides vitros tibc kit and vitros upro slides. to address this ocd will implement a software modification that will remove all non-supported dilution factors on the engen system.