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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A situation was identified where the cobas liat analyzer was manufactured and distributed with 3 assay scripts pre-loaded on the instrument. one of the assay script (cobas liat strep a) is not yet licenced in canada. however there is no user-impact since the assay is not available in canada and is not functional on the analyzer leading to no consequence on result reliability.