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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1. if during a manual bottle change the reset button is pressed with out actually changing the reagent the instrument will interpret the reset as fresh reagent being loaded and then use the reagent in the final tissue-processing step. the use of a degraded reagent in the final processing step can cause or contribute to tissue becoming unfit for diagnosis and if additional tissue is unavailable a rebiopsy may be required. 2. if a non-validated protocol is used or validated protocol is used inappropiately (i.E. wrong tissue sizetype or duration) this can cause or contribute to tissue becoming unfit for diagnosis and if additional tissue is unavailable a re-biopsy may be required.