There must be a documented system available in each Blood Establishment whereby adverse effects caused by the administration of any component, or the identification of a component quality problem, can enable the recall, if appropriate, of all unused components derived from that donation or all donations which are a constituent of a component pool. Similarly, there must be a documented system in each Blood Centre for the recall of any component or constituent of a component pool where reasonable grounds exist for believing it could cause adverse effects.
Any recall of a component should lead to a thorough investigation with a view to preventing a recurrence.
A system must be in place that ensures that any transfused (or discarded) blood component can be linked to the original donation and donor from which it was derived.7