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 received a customer complaint regarding a misread of a sample identification (id) number when using the external hand-held heron datalogic d-130 barcode scanner with the ortho provue analyzer. under certain conditions the barcode id displayed on the ortho provue analyzer screen may not match the barcode on the sample tube (i.E. the expected 6-digit barcode may be converted into a 9-digit barcode).