FDA grants Haemonetics clearance to collect two RBC on Cymbal system

Feb 23 2010

On January 27, 2010 the FDA cleared the Haemonetics (NYSE: HAE) 510(k) for its expanded nomogram to collect two Red Blood Cells on the Cymbal® Automated Blood Collection System from female donors who are at least 150 pounds and are 63 inches in height. The Cymbal is a small, portable, battery operated instrument that automates blood collection from volunteer donors, improving process control and helping alleviate blood shortages.

This expanded nomogram is identical to the FDA cleared claim for Haemonetics' MCS®+ automated system to collect red cells. Prior to this new approval, donors utilizing the Cymbal technology had to be 150 pounds and 65 inches. This approval allows blood collectors to expand utilization of the Cymbal technology to 3-6% more female donors supporting the blood center's abilities to optimize donor collections.