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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The access hav ab assay of product lot exhibits inconsistent patient dose response. this inconsistency may be manifested by erroneously low or high qc/sample dose results that could cause incorrect qualitative classification (i.E. false positive false negative false equivocal results) for the patient.