(P-QU-7) Current Blood Component Recalls in the United States

Sunday, October 20, 2024

12:00 PM - 1:00 PM

Presenting Author(s)

Yevgen Chornenkyy, MD MSc (he/him/his)

Beth Israel Deaconess Medical Center, Massachusetts, United States

Background/Case Studies: US blood suppliers must notify consignees via recalls and market withdrawals for blood components found to be non-compliant after issue. Recalls for regulation violations are listed online in weekly Food and Drug Administration Enforcement Reports (ERs). From 1990 to 2011, recalled blood components declined from 1:1500 to 1:5800 available units (Ramsey 2013, McCullough 2014). However, as derived from Alqemlas 2020, the 2013-2017 rate was 1:723. Analysis of current recall experience may be useful for quality improvement and transfusion risk assessment.

Study

Design/Methods: All blood component recalls in the 2023 ERs were analyzed by recall class, reason, number of units, and recommendations to notify the transfusion recipient’s physician (Ramsey 2013). Total available US units were from National Blood Collection & Utilization Surveys.

Results/Findings:

Results: The 2023 ERs had 607 recalls of 3341 blood components for a rate of 1:5412 available units (Table 1). There were no Class I recalls (possible serious adverse effects). Class II recalls (possible temporary/reversible adverse effects) comprised 85% of units (2861), Class III (adverse effects not likely) 15% (480). Five recalls (0.8%) of >100 units (range 109-645) included 51% of recalled units. The most common recalled units were red blood cells (RBCs) making up 58% (1667) of Class II and 73% (350) of Class III. For Class II RBC recalls, inappropriate arm preparation (654, 39%) and events related to infectious testing or donor exposure (506, 30%) represented the majority of units. For Class III RBC recalls, temperature deviations during storage or shipping (61, 17%), product preparation not according to specifications (56, 16%), and distribution of misbranded product (55, 16%) were the most common reasons for recall. Recent donor travel to malaria areas involved 55 units. The top general categories by total units were, collection (921, 27%), inadequate donor history and donor risks (853, 25%) and component preparation (651, 19%). The most common specific problems were incorrect infectious disease (ID) testing (637, 19%), inadequate arm preparation (545,16%) and collection sterility concern (117, 4%). The most concerning events for recipient physician notification were the incorrect ID testing, positive ID tests on recalled donations (syphilis 58 and Chagas 2 units), and prior positive donor ID tests (10 units).

Conclusions: The current incidence of recalled blood components is 1:5400 available units, similar to the 2010 era. Problems in donor screening, blood collection and component preparation accounted for 73% of recalled units, but the highest concerns for recipients were for violations of ID prevention requirements (21%). Recent approval of malaria testing for at-risk donors will mitigate malaria-travel recalls. Aggregated blood component recall statistics may help prioritize quality improvement measures to improve transfusion safety.