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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Manufacturer has determined that specific lots have shown decreased specificity for negative populations. the positive bias of approx. 0.3 index units and specimens with 0.5 to 0.8 index may be incorrectly identified as reactive for total antibodies to the core antigen of.