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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Siemens investigation confirmed that the introduction of a new syva polyclonal antibody lot (g1) for use in the dimension urine opiates screen has resulted in an alteration of specificity for levallorphan levorphanol nalorphine and oxycodone at the 300 and 2000 ng/ml cutoff concentration. as a result in the change in sensitivity to the cross reactant the claims for these compounds are no longer accurate for either the 300 or 2000 ng/ml cutoff as stated within the instructions for use (ifu). further investigation confirmed that syva beckman coulter and advia chemistry opiate reagents are impacted as well due to a common raw material used in the assays.