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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During the system initialization and exactly when the pipettors are washing if either patient sample or reagent area flap (door) are opened the shaker rod may stop moving. this will affect the suspension of magnetic particles resulting in low rlu values for calibrators controls and patient samples giving unexpected positive or negative results or incorrect dose.