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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Ocd has initiated a recall as it has determined that one lot of vitros white correction factor slides was released with an incorrect assay value for the 460nm wavelength filter. the labeling for the vitros white reference slides lot 9052-0045-6358 incorrectly indicates an assay value of 0.3785 for the 460nm filter versus the actual assay value of 0.8658. all other assay values listed are correct. the 460nm wavelength is only used to determine the predicted concentration when processing vitros tbil slides or vitros bubc slides.