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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Orhto clinical diagnostics has received customer complaints of intermittent imprecision outliers or shifts in control fluid values when using various lots of vitros chemistry products phbr slides (phenobarbital) from coating 0053. the investigation confirmed that biased values for patient samples could be obtained that may or may not be detected by quality control fluids.