Drug recall

Apheresis Red Blood Cells, Leukocytes Reduced

FDA recall event 92554 · Class II · Kentucky Blood Center Inc

Key facts

Event ID 92554
Recall numbers B-0525-2023
Recalling firm Kentucky Blood Center 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 product, collected by automated equipment that was not validated for use, was distributed.
Initiation date Apr 26, 2023
Report date Jun 28, 2023
Termination date Jun 22, 2023
City Lexington
State KY
Country United States
FEI number 1070402

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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