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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As a result of the investigation of a complaint regarding the product mentioned above the manufacturer inova diagnostics has confirmed that there is no visible precipitin line that develops between the ss-b positive control well and the ss-b antigen well on the nova gel plate within the expected 24 to 48 hour timeframe. this would result in an invalid test result and therefore no results would be reported.