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 ph is at 6.2 to 6.3 versus a specification of 6.5 to 6.9. the material contains a ph indicator (bromcresol purple) which is used as part of the mechanism of differentiation. the low ph is causing organisms that should give alkaline reactions to not give the correct reaction two complaints originating in the us (dec 2010 and june 2011) have been filed with the manufacturer in regards to failed ph results. both facilities properly prepared the medium and both found inconsistent performance based on quality control specifications. however proper qc was performed leading the facilities to not use the product.