NEW YORK (360Dx) – BioMérieux has received 510(k) clearance from the US Food and Drug Administration for two types of culture bottles used in quality control testing of platelets at blood banks using the firm's fully-automated blood culture system, the company announced today.
The BPA and BPN bottles are used in quality control testing of leukocyte-reduced apheresis platelet (LRAP) units using the firm's BACT/ALERT Virtuo system.
Among transfusable blood components, platelets have a short shelf life and a high contamination risk, BioMérieux said in a statement, so reliable quality control methods are essential to protect patients from bloodstream infections. The BPA and BPN culture bottles support the growth of aerobic and anaerobic organisms in two types of leukocyte-reduced units: apheresis platelet units, and whole-blood platelet concentrates from single units as well as pools of up to six.
The system is now commercially available to blood banks and transfusion services in the US and in countries that recognize CE marking, the company said.