We are a transfusion service and very infrequently prepare split units, pediatric units, and pooled cryoprecipitate units; do we need machine-readable labels for these units?

"The unit of blood or blood component label would contain the machine-readable information if the blood or blood component has any possibility of being transfused to a patient, whether or not the unit is actually transfused. Additionally, the phrase, "from which the blood or blood component can be taken and transfused to a patient" would include the circumstance where blood or a blood component is extracted or aspirated with a syringe from the container of blood or blood component in order to transfuse to a patient. This technique might be used when transfusing neonates or under other medically necessitated circumstances. In this case, the blood or blood component from which the aspirate is taken must have affixed to it a label containing the required machine-readable information. This would be consistent with the pre-existing requirement at § 606.121(c)(8)(iii) that requires specific statements if a product is intended for transfusion."