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 an increase in the rate of technical flags with the n latex ige mono reagent lots mentioned above. the errors can occur on calibration qc and/or patient sample. no result is given with the technical flag. in such cases a calibration curve cannot be established. in rare cases invalid qc results might be observed leading to invalid runs.