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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 52053
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
Distribution Pattern US States CA and NY. Nationwide to: Canada, United Kingdom, Germany, Israel, Spain, Japan, Singapore, and vietnam.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Micro SSPTM Allele Specific HLA Class I DNA Typing Tray - B*35 510(K) Number 8K 960062 Product number SSPR1-35 Product Insert Number SSP_DNAT_PIEN Rev 16 Product Name: Micro SSPTM Allele Specific HLA Class I DNA Typing Tray - B*35 Product Number: SSPR1-35 Lot Number: 002, batch 004 Expiration Date: 10/2013 Product Insert Number: SSP- DNAT-P-I EN Rev 16 510(K) Number BK 960062 Product Code MZI Class II HLA typing assay, associated with false negative results, was distributed. 1 unit B-2457-12