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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Manufacturer has identified a potential problem on the starrsed inversa esr analyzer. in case of a malfunction of the citrate distribution valve which is located on the diluter unit the blood sample may not be diluted correctly.