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 is conducting a recall for dimension vista 500 and dimension vista 1500 systems using software versions 3.4 and 3.5.1. there is a potential for the vial volume of in-use vista calibrators controls or sample diluent to incorrectly revert to full volume when removed and reloaded.