FDA Alert – Acrodose PLus and PL Systems by Haemonetics
ISSUE: Haemonetics recently received reports of low pH readings for platelets stored in the CLX HP bag in certain lots of the Acrodose PLus and PL systems. In some instances the drop in pH is accompanied by a yellow discoloration of the storage bag.
Platelets with pH lower than 6.2 and a lack of “swirl” may not be viable. Transfusion of these platelets may lead to delayed correction of coagulopathy or low quality prophylactic platelet transfusion, increasing risk of morbidity and mortality.
See the recall notice for a listing of affected product code and lot numbers.
BACKGROUND: Acrodose systems are closed systems for the pooling, and storage of leukoreduced whole blood-derived platelet concentrates.
RECOMMENDATION: Haemonetics is asking customers who received product affected by this recall to please discontinue use.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178