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 manufacturer is conducting a mandatory parameter upgrade(p-14.8)based on two fibrinogen-c reporting issues. issue number one was a result of 3 customer complaints where low abnormal fibrinogen sample reports were reporting as normal. issue two was identified by the manufacturer during r&d where high fibrinogen samples were reported as low.
Model Catalog: 0000280020 (Lot serial: 03110101 to 11111174); Model Catalog: 0000280030 (Lot serial: 03110101 to 11111174); Model Catalog: 0000280050 (Lot serial: 09120101 to 12060240); Model Catalog: 0000280040 (Lot serial: 08010200 to 12062270); Model Catalog: 0000280010 (Lot serial: 09080100 to 12060403); Model Catalog: 0000280000 (Lot serial: 03110101 to 11111174)