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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Specific chemiluminescent substrate lots have been shown to introduce a positive and/or negative bias in both controls and potentially patient results with multiple analytes assayed on the immulite 2000 and/or immulite 2500. siemens healthcare diagnostics has confirmed that the substrate lots may have impacted 31 immulite 2000 and immulite 2500 analytes.