FDA: Recall of Acrodose Plus and PL systems by Haemonetics

Editor's Note

The Food and Drug Administration (FDA) on April 13 announced the recall by Haemonetics (Braintree, Massachusetts) of certain lots of its Acrodose Plus and PL Systems because the company has received reports of low pH readings for platelets stored in CLX HP bags. In some instances the drop in pH is accompanied by a yellow discoloration of the bags.

Platelets with a pH lower than 6.2 may not be viable, and transfusion of these platelets may lead to delayed correction of a coagulopathy or a low quality platelet transfusion, increasing the risk of patient morbidity and mortality.