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 because ortho confirmed that if incubation time parameters are changed when creating a user defined protocol (udp) test then the incubation time of the ortho test template and other udp tests created from the same test template may change. the system will update the incubation time with the latest selection for all udps that use the same template and will also update the ortho test template.