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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Leica biosystems recently became aware that ta9217 lot 26806 contains mislabelled bond open containers. the containers display a research use only (ruo) label and the inclusion of these containers as part of the leica her2 fish system will prevent the user to be able to run the test. the bond instrument data management system (dms) software will not allow the ruo-labelled bond open container to be used as part of the sytsem.