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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Leica biosystems recently became aware that some detection kits may have been subject to a manufacturing error which could result in inadequate staining. if the product is used according to the instructions for use with the adequate controls the end user would be able to identify the test has not stained correctly.