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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Ocd has identified an anomaly with vitros system software version 3.0 & below on the vitros 3600 immunodiagnostic system vitros 4600 chemistry system and vitros 5600 integrated system. internal testing confirmed that under very specific conditions incorrect patient demographics were associated with a sample identification (id) number. this issue may occur when condition code py1-075 is generated for a sample id and the operator does not follow the instructions provided below in the condition review in v-docs.