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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 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
Recall Number B-2457-12
Classification Class II
Code Info 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
Product Distributed Qty 1 unit
Reason For Recall HLA typing assay, associated with false negative results, was distributed.

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