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 internal testing has determined that when a sample requires follow-up action such as dilution or retesting due to a mechanical issue it is possible for that sample to be routed to the sample storage drawer prior to completion of the necessary pending action. a delay in patient test result(s) reporting could occur. this affects engen laboratory automation systems configured with data innovations llc instrument manager v8.06.