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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Following internal investigation the manufacturer identified a situation where under specific conditions there is a possibility that un-spun samples could be incorrectly identified as spun by the spin status detection configuration of the cobas p512-p612 pre-analytical system when used in combination with dynamic interface system.