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 identified lots of ichem 10 sg urine chemistry strips (only lot 510033a was shipped to canada) may have leukocyte pads that are more sensitive at the first reporting range of 1+ corresponding to 25 white blood cells per microlitre leading to false positive leukocyte results for samples that are truly negative.