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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Manufacturer internal investigation revealed that the transfer of the nucleic acid contained in the eluates from the reagent cartridge to the elution tube was impacted with a frequency 0f 5%. only a certain portion of the eluated material was transferred to the elution tubes.