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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Product Detail

Product Description Micro SSP Allele Specific HLA Class I DNA Typing Tray-AB, Product Number: SSP1-AB, Lot 003, batch 007
Recall Number B-2458-12
Classification Class II
Code Info Micro SSP Allele Specific HLA Class I DNA Typing Tray-AB, Product Number: SSP1-AB, Lot Number 003, batch 007 Expiration August 2013. Product insert Number SSP_DNAT_PI-EN Rev 16; 510(K) Number BK960062; Product Code MZI
Product Distributed Qty 1 unit
Reason For Recall HLA typing assay, associated with false negative results, was distributed.

Event Detail

Event Id 55742
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 2012-03-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide in the US: OR and IL, and worldwide to Canada, Saudi Arabia/USA, United Kingdom, Germany, Italy, Jordon, Sweden, and Peru.
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