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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Micro SSP Allele Specific HLA Class I DNA Typing Tray-AB, Product Number: SSP1-AB, Lot 003, batch 007 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 Class II HLA typing assay, associated with false negative results, was distributed. 1 unit B-2458-12
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