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DATE RECALL INITIATED:
July 21, 2004
PRODUCT / PRODUCT CODES:
Amicus Separator apheresis device, product codes 4R4580 and 4R4580R, installed with software version 2.51
MANUFACTURER:
Baxter Healthcare Corporation
Round Lake, IL 60073
REASON:
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.
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.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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