Human health risks are naturally of primary concern to those who may be affected. Responsibility for initial detection, investigation and reporting lies with clinicians. Procurement organizations, tissue and cell processors play an essential role in quarantine, investigation and recall of potentially implicated allografts. Adverse reactions that have been confirmed ultimately become the responsibility of competent authorities when they rise to the level of governmental attention. Global distribution of tissues and cells requires communications among national competent authorities to ensure effective risk mitigation.