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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Product Detail

Product Description Platelets Pheresis Leukocytes Reduced
Recall Number B-0011-14
Classification Class II
Code Info W158013801466;
Product Distributed Qty 1
Reason For Recall Blood product, collected without the performance of a WBC count during instrument re-validation, was distributed.

Event Detail

Event Id 66388
Product Type Biologics
Status Terminated
Recalling Firm Arup Laboratories, Inc.
City Sandy
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-05
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Utah