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 manufacturer gen-probe gti diagnostics has recently notified us that they have observed anomalous increases in the optical density (od) of the negative control used with certain lifecodes pak12g assay lots. this may result in an increase in invalid runs as the kit ages. therefore they have decided to withdraw the affected lots from the market.