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Pooled Cryo labeling after thawing


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From 21CFR606 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

Sec 606.121(c) Container label.

(13) The container label of blood or blood components intended for transfusion must bear encoded information in a format that is machine-readable and approved for use by the Director, CBER.

(i) Who is subject to this machine-readable requirement? All blood establishments that manufacture, process, repack, or relabel blood or blood components intended for transfusion and regulated under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act.

(ii) What blood products are subject to this machine-readable requirement? All blood and blood components intended for transfusion are subject to the machine-readable information label requirement in this section.

(iii) What information must be machine-readable? Each label must have machine-readable information that contains, at a minimum:

(A) A unique facility identifier;

(B) Lot number relating to the donor;

(C) Product code; and

(D) ABO and Rh of the donor, except as described in paragraphs (c)(9) and (i)(5) of this section.

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AABB Standards 28th Edition

Reference Standard 5.1.8A

 

Cryoprecipitate, thawed, Single Unit: 6 hours

Cryoprecipitate, thawed, Pooled-Open System: 4 hours

Cryoprecipitate, thawed, Pooled using a sterile connection device (closed system): 6 hours

Storage and Transport for all three products: 20-24o C

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If all you are doing is thawing pre-pooled cryo and transfusing it, then you are not required to relabel the product and you only need to cross out the old expiration and hand write the new expiration date/time.  You can optionally choose to relabel the product as Thawed Pooled Cryo and bar code the new expiration date/time but this is not required.

If you are thawing individual cryo units and then pooling the thawed single units together, then you are required to relabel the product. 

Erwin Cabana

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