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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Certain lots of barcode clips can cause aborted patient run due to a molding defect. as a consequence the cap instrument will lift the sample input tube together with the barcode clip from the sample rack resulting in an aborted run. no false result can be generated.