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 discrepant results (false negative results) reported from the field biomerieux initiated a complaint investigation. a loss of performance due to light exposure after 3 months of shelf life for api zym b which lead to false negative results on some api strips using the zym b (api 20 strep-20600 api coryne-20900 api staph-20500 api zym-25200 api nh-10400 api listeria-10300).