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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Linearity failure in samples with low concentrations of alpha1-antitrypsin (aat) when analyzed using the affected aat lots. samples with target values below 80 mg/dl may recover up to 20% low when reported from the initial 1:216 dilution.