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The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Specific Label Statements

These specific statements must be on the label:
  • For Whole Blood, Plasma, Platelets, and partial units of Red Blood Cells, the volume of the product, accurate to within + 10 percent; or optionally for Platelets, the volume range within reasonable limits.
  • The recommended storage temperature (in degrees Celsius)
  • If the product is intended for transfusion, the statements:
    • "Rx only"
    • "See circular of information for indications, contraindications, cautions, and methods of infusion"
    • "Properly identify intended recipient"
  • If the product is intended for transfusion, the ABO and Rh groups of the donor must be designated conspicuously. (For cryoprecipitated AHF, the Rh group may be omitted).
  • The statement, "This product may transmit infectious agents."
The Circular of Information (instruction circular) is the information provided to the end user of a blood component that cannot be squeezed onto the label. The instruction circular provides infusion details, indications, warnings, description of products, and possible reactions. This can be obtained from the blood supplier and should be made available to anyone in the transfusion service who transfuses blood components.