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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Some patient sample results may be difficult to interpret due to weaker avidity of ab when using the igg antiserum included in the kits affected. dk.
Model Catalog: (Lot serial: P/N 444970 LOTS M307327-307333); Model Catalog: (Lot serial: P/N 444970 LOT 305176); Model Catalog: (Lot serial: P/N 444970 LOTS M310301-310305); Model Catalog: (Lot serial: P/N 446260 LOT M309039); Model Catalog: (Lot serial: P/N 446360 LOT M308363)