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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Product Detail

Product Description 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.
Recall Number B-0387-13
Classification Class II
Code Info 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).
Product Distributed Qty 2
Reason For Recall TerumoBCT Vista version 3.2 software, with a defect or glitch causing donors to be incorrectly deemed eligible, was distributed.

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.
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