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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Detail

Product Description Micro SSP DNA Typing Trays Micro SSP High Resolution HLA Class II DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Recall Number B-1424-13
Classification Class III
Code Info Catalog Identification: SSP2H Lot Number: 04A and 005
Product Distributed Qty 2
Reason For Recall Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed.

Event Detail

Event Id 32603
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 2013-02-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US states nationwide. International: Canada, U.A.E, Saudi Arabia, Cyprus, UK, France, Germany, Greece, Israel, Italy, S.Africa, Jordan, Kuwait, Lebanon, Poland, Serbia, Croatia, Seria, Montenegro, Austria, Netherlands, Russia, Finland, Spain & Portugal, Turkey, Russia, Finland, Brazil, Argentina, Australia, Qatar, Bangladesh, Korea, China, Chile, Bolivia, Paraguay, Costa Rica, Ecuador, Guatemala, India, Japan, Mexico, Malaysia, New Zealand, Peru Philippines, Pakistan.