Drug recall

Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated

FDA recall event 88828 · Class II · OneBlood, Inc.

Key facts

Event ID 88828
Recall numbers B-0016-2022
Recalling firm OneBlood, Inc.
Product type Biologics
Products Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
Classification Class II
Status Terminated
Voluntary or mandated Voluntary: Firm Initiated
Reason for recall Apheresis Red Blood Cell products, for which quality control for residual WBC count was not performed, were distributed.
Initiation date Aug 17, 2021
Report date Nov 3, 2021
Termination date Oct 26, 2021
City Orlando
State FL
Country United States
FEI number 1072425

At a glance

  • 1–9 Products in this recall
  • 10–99 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA drug and product recalls

FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.

Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date:

Browse all FDA drug and product recalls