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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A leaking stopcock spare part (922640 rev.02) used in the autostainer isntrument family has been obersved. feedback from service engineers indicate that the stopcock component of the syringe assembly is leaking around the plunger in the stopcock when the prove is being washed/flushed. this could result in a reduced intensity score giving a false negative result in harceptest but does not affect the clinical outcome of any other reagents.