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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 65358
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 2013-05-22
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern USA, Canada, Germany, Israel, Poland, Spain, Brazil, Japan, Singapore, Thailand, and Vietnam.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Micro SSP" Allele Specific HLA Class I DNA Typing Tray B*38/39, Catalog Identification: SSPR1-16 Micro SSP" Allele Specific HLA Class I DNA Typing Tray B*38/39 Catalog Identification: SSPR1-16 Article Number: SSP_DNAT_PI Rev 18 Lot number: 002, batches 001-003 510(K) Number : BK960062 Micro SSP" Allele Specific HLA Class I DNA Typing Tray B*38/39 Catalog Identification: SSPR1-16 Article Number: SSP_DNAT_PI Rev 18 Lot number: 002, batches 001-003 Class II Micro SSP Allele Specific HLA Class I DNA Typing Trays (B*38/39), manufactured with an incorrect primer, were distributed. 1 device distributed B-2026-13
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