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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There is evidence that in a portion of the affected lot there is a cross-contamination with lithium heparin in a concentration not exceeding 1.2 iu per milliliter in plasma obtained from properly filled tubes (note: this value was obtained from healthy subjects using a limited number of tubes from the affected lot). the internal investigation completed by bd indicates that this contaminant can adversely affect coagulation results. erroneous results may lead to inappropriate decisions regarding patient care. for a full listing of assays that may be adversely affected by the lithium heparin contaminant please contact the manufacturer.