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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Immucor is recalling the galileo echo instrument to effect a change to the rh phenotype assays. the potential hazard is that the instrument could give a false positive result which could cause a blood mistype.