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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The stability of the specified lots of the kallestad anti-mpo (panca) microplate eia test kit has declined over time. the manufacturer has observed that the optical density (od) and value of arbitrary units of the positive control decreases over time eventually causing an invalid test.