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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Based on investigation of incorrect results related to the college of american pathologists (cap) surveys mrs5-a 2014 and mrs5-b 2014 using the bd-max mrsa assay it was confirmed that one of the samples for each of the surveys yielded some false positive results. while there is the potential for false positive result for specimens from patients who are positive for certain strains of methicillin-sensitive staphylococcus aureus (mssa) when present at high loads bd believes that such an occurence is unlikely and overall clinical performance would not be affected.