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 of a customer complaint the manufacturer identified a situation where the cobas 8100 system reformatter module brf sw version 02-xx may cause sample racks crash potentially leading to be shaken and specimen to be spilled. there could be an impact on the test performance since a cross-contamination cannot be excluded and could lead to erroneous results. the manufacturer advised us of this on 20-feb-2017.