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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The manufacturer has identified during an internal investigation following a customer complaint that a poor quality barcode (code 128 grade f) could generate a misidentification using the handheld scanner usb it3800 (cat # 05401062001 included in the mentioned roche systems.