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 high rate of dilution check relative bias failures of greater than 2% when using v-lyte dilution check solution lots kc6d01 kc6f01 or kc6j01. newer lots of dilution check starting with kc7a01 are not affected by this issue.