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 hla-b27 fitc/cd3 pe reagent in the bdt hla-b27 kits is contaminated with cd4 pe and expresses itself as a presence of an additional dim cd3+ monocyte population (noted in the red circle of image provided in the customer letter) and a split in the bright cd3 population which prevented the software to gate on facscanto instruments. (this could in rare circumstances lead to a false positive result. gating failure would result in the inability to generate a result and thus cause a delay in the diagnostic process).