REGULATORY UPDATE: FDA Reminds Facilities and Manufacturers About Risks of Septic Reactions to Platelet Transfusion, Encourages Immediate Reporting of Any Occurrences

The Food and Drug Administration (FDA) on Nov. 5 issued important information reminding blood establishments, transfusion services and device manufacturers that septic reactions to platelet transfusion can occur despite pathogen reduction or bacterial testing. The communication also stressed that suspected transfusion reactions should be reported immediately to the blood supplier.

Since May 2025, FDA has received reports of septic reactions after transfusion of pathogen-reduced platelets, including two fatalities. It has also received reports of two fatalities after transfusion of apheresis platelets prepared with other bacterial mitigation strategies.

In the recent communication, FDA reiterated that blood establishments and transfusion services must investigate suspected septic transfusion reactions and notify FDA as soon as possible of confirmed fatalities. Additionally, device manufacturers must report when their device may have caused or contributed to a serious injury or patient mortality.

Members with questions are invited to contact regulatory@aabb.org.