Drug recall

Apheresis Red Blood Cells, Leukocytes Reduced

FDA recall event 90054 · Class II · OneBlood, Inc.

Key facts

Event ID 90054
Recall numbers B-0356-2022
Recalling firm OneBlood, Inc.
Product type Biologics
Products Apheresis Red Blood Cells, Leukocytes Reduced
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 Mar 28, 2022
Report date May 18, 2022
Termination date May 10, 2022
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.

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

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