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 5600 integrated system software version 1.6 and below. internal testing determined that under very specific conditions a surfactant addition may inadvertently be added to a cuvetip or an empty cuvetip position for which it was not intended. please refer to the customer letter for details of the specific conditions in which this event may occur.