Drug recall

Apheresis Platelets, Leukocytes Reduced

FDA recall event 80105 · Class II · Medic Inc

Key facts

Event ID 80105
Recall numbers B-0585-2018
Recalling firm Medic Inc
Product type Biologics
Products Apheresis Platelets, Leukocytes Reduced
Classification Class II
Status Terminated
Voluntary or mandated Firm Initiated
Reason for recall Platelet products, which failed quality control testing for platelet count, were distributed.
Initiation date Jul 28, 2017
Report date Jun 6, 2018
Termination date May 30, 2018
City Knoxville
State TN
Country United States
FEI number 1077605

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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