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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The prepstaint instrument automatically prepares and stains slides for cytology. stains and rinses are applied to the sample in order to prepare the slide for cover slipping. a centrifuge is used as part of the sample preparation process. the centrifuge tube rack #2 is keyed incorrectly not allowing proper alignment of the tube holders with the prepstain waste station. this could result in potential delays in processing of slides and thus create potential delays in reporting of patient results.