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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Event Detail

Event ID 65463
Product Type Biologics
Status Ongoing
Recalling Firm Blood Bank Computer Systems, Inc
City Auburn
State WA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-23
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Blood Bank software Primary Application with Model numbers and 5.4.1. BBCS Primary Application, 5.4.1 Class II Blood Bank software Primary Application (Model Numbers and 5.4.1), with a defect or glitch, was distributed. 2 Devices B-2148-13