FDA Issues Warning Over Leukotrap RC System Blood Filters

FDA is warning healthcare providers of faulty filters used in Haemonetics’ Leukotrap RC System that are associated with higher-than-expected levels of leukocytes in transfused blood.

The company initially alerted healthcare providers in a recall notice dated June 8, warning of three recent lots of the Leukotrap RC System filtered with its RC2D filter could yield blood products with a high leukocyte count.

The global manufacturer received further reports of higher than expected residual white blood cell counts associated with lot numbers beyond those described in the June 8 recall.