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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 62501
Product Type Biologics
Status Terminated
Recalling Firm Sunquest Information Systems, Inc.
City Tucson
State AZ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-12-14
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Sunquest Laboratory Blood Bank and Blood Donor Sunquest Blood Bank and Blood Donor versions: Sunquest Blood Bank and Blood Donor versions 6.0.1 Distributed with Sunquest Laboratory 6.1; 6.0.1 Distributed with Sunquest Laboratory 6.2; 6.0.2 Distributed with Sunquest Laboratory 6.3; 6.4 Distributed with Sunquest Laboratory 6.4 Class III Software, with a glitch or defect, was distributed. 4 products B-2202-12
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