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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Customers have reported stain fading and difficulty with cell and morphology identification after the stain has been onboard in the stain baths for more than two hours. -cells and their morphology may be difficult to identify. -there is a remote probability of a delay in delivery of patient results due to the lack of availability of a properly stained blood film for a leukocyte differential.