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 has identified a software anomaly that can occur with analyzers connected to the bypass modules listed on an engen laboratory automation system using tcautomation software version 3.1.1 and below. when this anomaly occurs it is possible for a sample other than the intended sample to be aspirated potentially leading to test results being assigned to the wrong patient without error notification.