Plasma for fractionation, Australian Red Cross Lifeblood, CON-1155
Product name
Plasma for fractionation
Sponsor name
Australian Red Cross Lifeblood
ARTG
Consent start
Consent no.
CON-1155
Standard
The stated reason for the change in Guidelines for the Selection of Blood Donors (GSBD) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
Where single-use equipment is used, and it is less than 4 months since the
procedure, Lifeblood accepts the donor for plasma for fractionation.
Conditions imposed
1. The consent to supply those goods that do not conform to standards is
restricted to donors who donate plasma for fractionation and does not include
fresh blood products intended for clinical use.
2. The consent to supply is subject to the continued acceptance of CSL Behring
who are responsible for plasma fractionation processes.
Therapeutic product type
Blood, tissues, and biologicals