Reconstituted Apheresis RBC Labeling

[Tmccoll]

All the examples of reconstituted RBC labels I’ve found include RBCs from whole blood (Guidance and US Consensus Standard). I’d like to know what language is required by FDA/ICCBBA for reconstituted RBCs from apheresis. Does anyone know where I can find the requirements? Thanks

[Cliff]

6 hours ago, Tmccoll said:

All the examples of reconstituted RBC labels I’ve found include RBCs from whole blood (Guidance and US Consensus Standard). I’d like to know what language is required by FDA/ICCBBA for reconstituted RBCs from apheresis. Does anyone know where I can find the requirements? Thanks

Are you registered with ICCBBA?  You can download the database.

If not, contact them.  iccbba@iccbba.org

[Tmccoll]

Thanks for the reply. Are you referring to the product code database? I was looking for examples of the label design for reconstituted RBCs from apheresis.

I may need to contact ICCBBA. Thanks again.

[Cliff]

1 hour ago, Tmccoll said:

Are you referring to the product code database? 

Yes

1 hour ago, Tmccoll said:

I was looking for examples of the label design for reconstituted RBCs from apheresis.

I am not promoting one company over another, but we've had good luck with Shamrock labels.  If they don't have what you need, they'll make a custom label.  All of our product modification labels from from our LIS.