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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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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
Distribution Pattern Utah

Product Detail

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