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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It has been confirmed that one of the positive qc strains enterococcus faecalis atcc 19433 was not reproducible when tested on vitek ms following culture on the trypcase soy agar + 5% sheep blood (tss) media. during development this enterococcus faecalis atcc 19433 strain was tested after culture on the colombia agar + 5% sheep blood media. therefore the culture of this strain on the trypcase soy agar + 5% sheep blood (tss) media was never validated.