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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An internal investigation has confirmed occurrences of atypical negative o129r reactions for enterococcus casseliflavus atcc 700327t in association with three (3) vitek 2 gp id lots causing failure of the quality control (qc) testing for the vitek 2 gp id card.