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.
데이터 추가 비고
원인
A staining artefact has been observed on stained slides that may interfere with the interpretation and identification of acid-fast bacteria (afb) which is the indication for this assay. this artefact can be described as circular non-specific purplish-color slide background and the color can vary from blue to pink to purple. the staining artefact has the potential for obstructing visualizagion of acid-fast bactery therefore leading to the potential for false positive or negative results.