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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Siemens healthcare diagnostics has confirmed a low frequency defect in the molding of the loci reaction vessels. the lip (flange) of the vessel is non-uniform or very thin in comparison to a normal vessel. this defect may result in vessel pick-up errors or vessel jams when the vessel is being loaded. patient results are not impacted however there may be a delay in sample report time.