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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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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
Distribution Pattern U.S.A., Saudi Arabia, and Hong Kong.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Catalog ID - DR72; Lot Number - 030; Batch 087 Class III HLA typing assay, associated with false positive results, was distributed. 1 Product B-0499-14