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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Event Detail

Event ID 63300
Product Type Biologics
Status Terminated
Recalling Firm One Lambda Inc
City Canoga Park
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-08-22
Initial Firm Notification of
Consignee or Public
Distribution Pattern US, Canada, Saudi Arabia, Brazil, China, Japan, Mexico, New Zealand, Puerto Rico, Singapore, Taiwan, and Thailand.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
LABScreen® Product  LABScreen® Single Antigen HLA Class II Antibody Detection Test -GROUP 1 Product Number: LS2A01 510(K) Number : BK 030069 Product Code : MZI PMA Number : N/A Preamendment : No Product Number: LS2A01 Lot Numbers : 003 - 008 Expiration Date: Lot 003 11/2007 Lot 004 09/2008 Lot 005 10/2009 Lot 006 05/2010 Lot 007 04/2012 Lot 008 04/2013 Product Insert Number: LS_LSCN-PI-EN-00, Rev. 17 Class III LABScreen HLA Class II Antibody Detection Test, associated with false reactions with the DP20 antigen, was distributed. 6 B-0091-13