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) has initiated a recall due to the potential for false positive reactions when using specific lots of anti-human globulin anti-igg (rabbit) mts anti-igg cards (mts anti-igg cards). it has been determined that affected mts anti-igg card lots may exhibit a varying low-level activity of anti-complement that may result in a false positive test.