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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Of 18000 treatments performed to date therakos received three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the cellex photopheresis system. the investigation suggests that heat generated in the centrifuge chamber may be responsible for red cell changes that may rarely result in post reinfusion hemolysis or hemoglobinuria. the purpose of the recall notification is to provide customers with recommended actions intended to reduce heat build-up in the centrifuge chamber of the cellex system.