Fast-breaking News from AABB PulsePoints
	The following has been reproduced from the August 10, 2004 AABB PulsePoints, an electronic news alert provided by the American Association of Blood Banks.

August 10, 2004
No. 651

Recall of Amicus Separator Apheresis Device

AABB PulsePoints

Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), on August 9, 2004, updated a recall notice for the Amicus Separator apheresis device as listed below.  The product is manufactured by Baxter Healthcare Corporation in Round Lake, Ill.

According to the recall notice issued by CBER, “Baxter Healthcare Corporation received four user reports that the Amicus Separator collected more plasma in the course of an apheresis procedure than desired or collected plasma when none was targeted.  In all cases, the error occurred during the single needle platelet collection procedure with the concurrent collection of red blood cells, and the devices had software version 2.51 installed.”  In addition, it is stated in the notice that, “The firm has determined that the method used by software version 2.51 to calculate plasma collected at various points during the procedure can be optimized.  The firm plans to release a new software version that will return all excess plasma collected during reinfusion at a controlled rate determined by the donor's weight.”

DATE RECALL INITIATED:
July 21, 2004

PRODUCT / PRODUCT CODES:
Amicus Separator apheresis device, product codes 4R4580 and 4R4580R, installed with software version 2.51

To view CBER’s recall notice, visit: http://www.fda.gov/cber/recalls/amicbax072104.htm.