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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The risk to use the product beyond the expiration date due to the incorrect label is to have false results. the severity level of the risk to obtain false results (due to the insufficient extraction) has been assessed as critical considering that the product is used in the extraction phase of the nuclisens and r-gene tests and it is also used always in the extraction phase in association with other kits not manufactured by biomerieux. medical affairs confirmed the severity of the issue as critical for adverse health consequences and mitigated the occurrence as remote (unlikely to occur but is possible).