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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Hemosil factor xii deficient plasma are not meeting their labeled on-board instrument stability claim for the alc top family and acl top family 50 series of 24 hours at 15c the affected lots numbers are only stable for 2 hours on-board the instrument. consequently there is a potential risk of falsely lowered patient results if this reagent is maintain greater than 2 hours on-board the instrument.