CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
May 29, 2020—BioMérieux’s BACT/Alert BPA and BPN culture bottles received 510(k) clearance from the FDA for Large Volume Delayed Sampling of leukocyte-reduced apheresis platelets and leukocyte-reduced whole blood platelet concentrates with BACT/Alert 3D and Virtuo systems. The FDA’s 2019 guidance recognizes LVDS as an effective strategy to control the risk of bacterial contamination in platelets and extend their shelf life to seven days with a single-step approach.