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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Anomalous increases in the optical density (od) of the negative control used with a certain lifecodes pak plus assay lot with the igg conjugate. this may result in decreased sensitivity for some analytes as the kit ages. therefore the manufacturer has decided to withdraw the affected lots from the market.