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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description Terasaki HLA Tissue Typing Trays (HLA Class II Tissue Typing Trays only). Terasaki HLA Tissue Typing Trays are for use in determining HLA cell surface antigens with a complement dependent microlymphocytotoxic technique. BK840023
Recall Number B-0499-14
Classification Class III
Code Info Catalog ID - DR72; Lot Number - 030; Batch 087
Product Distributed Qty 1 Product
Reason For Recall HLA typing assay, associated with false positive results, was distributed.

Event Detail

Event Id 67613
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 2014-02-17
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern U.S.A., Saudi Arabia, and Hong Kong.