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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In engen systems with tcautomation (tca) software v2.6 v3.2 and v3.5 configured with bypass modules for advia centaur abbott architect vitros and/or tosoh aia systems a sample tube carrier being released in the bypass module may not be detected and therefore the next sample to be metered may not advance for processing. no error message will be posted if this occurs. the bypass module will stop processing samples indefinitley until an operator detects the issue and intervenes.