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Safety Notice for THERAKOS™ CELLEX™ Photopherese System

Product group Injections / Infusions / Transfusions / Dialysis
Reference 04052/11

THERAKOS has issued a Field Safety Notice on post reinfusion hemolysis or hemoglobinuria in patients treated on the 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.

Safety Notice for THERAKOS™ CELLEX™ Photopherese System , Download_VeroeffentlichtAm_EN PDF, 59KB, File does not meet accessibility standards