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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Bacterial contamination (pseudomonas mendocina) in the affected device. the device is a cell separation media and in the reported instance was used to isolate stem cells from bone marrow specimens. the isolated cells were placed into cell culture for further testing and contamination was evident after 14 days of culture. the laboratory confirmed the source of contamination was the device.