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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Detail

Product Description HLA Fusion Software; version 2.0.0 SP4.1, Catalog ID FUSPGR
Recall Number B-2326-13
Classification Class II
Code Info HLA Fusion Software (version 2.0.0, SP4.1; Catalog ID FUSPGR (With Luminex xPONENT Software 3.1)
Product Distributed Qty 1
Reason For Recall HLA Fusion Version 2.0.0-SP4.1, with a defect or glitch causing a conversion error giving incorrect test results for certain beads, was distributed.

Event Detail

Event Id 65911
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 2013-07-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US nationwide and international: Canada, Saudi Arabia, UK, France, Germany, Greece, Italy, Romania, Slovenia, Netherlands, Russia, Finland, Sweden, Spain and Portugal, Brazil, Chile, Bolivia, Paraguay, Costa Rica, Japan, South Africa, Turkey, Vietnam, China, and Malaysia.