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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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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
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
HLA Fusion Software; version 2.0.0 SP4.1, Catalog ID FUSPGR HLA Fusion Software (version 2.0.0, SP4.1; Catalog ID FUSPGR (With Luminex xPONENT Software 3.1) Class II 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. 1 B-2326-13