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 investigating reports of unexpected positive reactions with the tpha screen assay performed on the neo and galileo instruments. the investigation to date has identified a shift in performance with the tpha screen associated with higher rates of unexpected positive reactions.