Indications for Use
The ACP 215 is intended to glycerolize and deglycerolize red blood cells derived from whole blood that have been stored in any approved anticoagulant/additive solution for up to 6 days at 1-6°C prior to glycerolization.
Red blood cells, derived from whole blood collections and non-leukoreduced, that have been collected and stored in CPDA-1, glycerolized using the ACP 215 and frozen at -80°C, and deglycerolized using the ACP 215 and stored in Haemonetics AS-3 at 1-6°C may be labeled for extended storage for 14 days.
In addition, red blood cells that have been collected and stored in CPD/AS-1 or CP2D/AS-3, leukoreduced, glycerolized using the ACP 215, frozen at -65°C or colder, deglycerolized by the ACP 215, and stored in Haemonetics AS-3 at 1-6°C maybe be labeled for extended storage for 14 days.
Red blood cells collected in any other anticoagulant/additive solution will be labeled with a 24-hour outdate.
Red cells, non-leukoreduced, that were manually glycerolized using the 50% W/V glycerol (Valeri Method) and frozen at -65°C or colder may be deglycerolized using the ACP 215 and labeled with a 24 hour outdate.
Please refer to the manual for indications for use, contraindications, warnings, precautions and potential adverse events.