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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Manufacturer has documented a potential risk of data loss when affected base units (used in parallel with point of care instrumentation) are using a usb connection for data transmission to a data management system (cobas it1000 or any other 3rd party dms). although the occurrence is rare in the worst case scenario this issue could lead to an erroneous assignment of patient data.