• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description 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
Recall Number B-2026-13
Classification Class II
Code Info 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
Product Distributed Qty 1 device distributed
Reason For Recall Micro SSP Allele Specific HLA Class I DNA Typing Trays (B*38/39), manufactured with an incorrect primer, were distributed.

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.
-
-