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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There is a high bias on results greater than 30 ng/ml (95.4 nmol/l) when compared to the master curve when using select advia centaur progesterone kit lots. the high bias may cause neat serum samples with results greater than 60 ng/ml (190.8 nmol/l) to recover within the assay range upon dilution (dilution factor applied). samples with values below 30 ng/ml (95.4 nmol/l) do not demonstrate this bias.