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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Inova diagnostics inc recently discovered that some of the glass slides have the incorrect product description on the masking of the slide. approximately 3% of the glass slide lot received from the supplier contains the incorrect description of "e anca" instead of "hep-2" on the masking. the barcode on the glass slide correctly reflects the "hep-2" product information and the performance of the slides is not in any way affected by this error.