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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Seven customers reported cartridge performance with a higher number of invalid results than would typically be expected with the kit and its intended use specimen types. cepheid investigated the complaints and found that the complaints were valid. the failure investigation identifies six kit lots that were affected. only one of the lots were imported and sold in canada.