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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Product Detail

Product Description 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
Recall Number B-0091-13
Classification Class III
Code Info 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
Product Distributed Qty 6
Reason For Recall LABScreen HLA Class II Antibody Detection Test, associated with false reactions with the DP20 antigen, was distributed.

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 E-Mail
Distribution Pattern US, Canada, Saudi Arabia, Brazil, China, Japan, Mexico, New Zealand, Puerto Rico, Singapore, Taiwan, and Thailand.