Patient PC needed a transfusion of an irradiated red blood cell (RBC) unit. ABC Blood Center shipped the unit to the hospital. The unit was labeled as irradiated but did not complete the irradiation process. The RBC unit was issued to the nursing unit for transfusion to Patient PC. The unit was not transfused and was returned to the laboratory. The laboratory was notified by ABC Blood Center of the labeling error later that day. Is this a reportable deviation to the FDA? State your reasons for your decision.