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 (ortho) identified the potential for intermittent imprecision in results generated using affected lots of vitros li slides. when present the potential imprecision does not affect random slides but rather sequential slides within or across slide cartridges caused by a short-duration imperfection during manufacturing.