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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During the stability study of a new batch of zym b reagent (70493) a visual defect has been observed. after three months of stability this batch presents an heterogeneous aspect of color from yellow to red (a color yellow to amber is considered as conform according to the package insert). this visual defect is due to a specific new batch of raw material (lot mkbp5202v of fast blue bb salt sigma) used for the manufacturing of several batches of fb reagent and zym b reagent. as the involved batches of zym b reagent are included inside of api nh (10400) and api listeria (10300) kits the both references are also impacted.