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Medical Devices / Postmarket Safety

TGA Issues Alert for Blood Treatment Device

March 13, 2018

Australia’s Therapeutic Goods Administration is investigating a safety concern involving Therakos’ Cellex photopheresis system.

The device treats patients’ blood with a photosensitizing agent and returns it to the patient’s body, a process that can be used to treat cutaneous T-cell lymphoma and graft versus host disease.

Over the past nine years, the TGA has received 13 reports about the system, one of which concerned a severe allergic reaction linked to either the device itself or a drug associated with its use, and the other involving broken, leaking or missing components.

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