How is the normality of CRYOcheck Pooled Normal Plasma verified?

All plasmas used in the manufacture of CRYOcheck Pooled Normal Plasma are tested and found negative when screened for Lupus Anticoagulants. Each lot number has been verified to be normal for factors II, V, VII, VIII, IX, X, XI, and XII; and they have PTs, APTTs and fibrinogen in the normal range. CRYOcheck Pooled Normal Plasma is manufactured from 20 or more donors. We provide (by customer request) quality documentation verifying the factor levels for every lot of CRYOcheck Pooled Normal Plasma we manufacture.