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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 Product Name: LABType® HD Class II DRB1 Typing Test Product Number: RSSOH2B1/RSSOH2B1X Lot Number: 07B Expiration Date: 03/2014 Product Insert Number: RSSO_LTYP_PI_EN Rev 21
Recall Number B-0340-13
Classification Class II
Code Info Lot Number: 07B Expiration Date: 03/2014 Product Insert Number: RSSO_LTYP_PI_EN Rev 21
Product Distributed Qty 1
Reason For Recall HLA typing assay, associated with incorrect typing results, was distributed.

Event Detail

Event Id 63601
Product Type Biologics
Status Ongoing
Recalling Firm One Lambda Inc
City Canoga Park
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Domestic and international consignees. US Sates nationwide, Canada, Saudi Arabia, UK, France, Germany, Italy, Russia, Sweden, Portugal and Spain, Turkey, Brazil, China, Chile, Japan, and Malaysia.
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