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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Event Detail

Event ID 47926
Product Type Biologics
Status Terminated
Recalling Firm Northwest Florida Blood Center, Inc.
City Pensacola
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-01-16
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern FL, AL

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced Irradiated 5220672 Class II Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. 1 unit B-1653-13
Red Blood Cells 4668249 Class II Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. 1 unit B-1654-13
Red Blood Cells Leukocytes Reduced 4360813; 4360796 Class II Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. 2 units B-1655-13
Platelets Pheresis Leukocytes Reduced Irradiated 4668239A; 4668239B Class II Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. 2 units B-1656-13
Platelets Pheresis Leukocytes Reduced 4571232A; 4571232B; 4927022A; 4927022B; 4927021A; 4927021B. Class II Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. 6 units B-1657-13
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