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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Event Detail

Event ID 39434
Product Type Biologics
Status Terminated
Recalling Firm Life Sera, Inc.
City Clarkston
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2004-12-29
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Germany

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Source Plasma FT01233251; FT01233373; FT01233495; FT01233601 Class II Blood products, which tested negative for the human immunodeficiency virus (HIV) but were collected from a donor who previously tested positive for HIV, were distributed. 4 units B-1169-13