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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Event Detail

Event ID 63190
Product Type Biologics
Status Ongoing
Recalling Firm CaridianBCT, Inc.
City Lakewood
State CO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-17
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US distribution only: VA, MS, SC, AZ, TN, MI, TX, PN, CA, NY, CA, UT.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Vista System Version 3.2 service pack 3 used on Trima Accel Automated Collection System version 5.1 or User Defined Machines. The software is used for determining donor eligibility based on annual Red Blood Cell Volume Loss Limits. Vista Version 3.2 Service Pack 3 (stand alone Service Pack) part number 923000-326 and Vista V3.2 with Vista 3.2 Service Pack 3 (part number 923000-327B). Class II TerumoBCT Vista version 3.2 software, with a defect or glitch causing donors to be incorrectly deemed eligible, was distributed. 2 B-0387-13
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