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Health product recall

Micro SSP Allele Specific HLA Class I DNA Typing Tray-C*02 (2014-03-25)

Starting date:
March 25, 2014
Posting date:
August 28, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-41233

Recalled products

  1. Micro SSP Allele Specific HLA Class I DNA Typing Tray-C*02 

Reason

Micro SSP Allele Specific HLA Class I DNA Typing Tray-C*02, the primer in well 1/7/c is incorrect.  As a result, the allele C*02:04 cannot be correctly assigned and may cause an ambiguous misassignment to C*02:27:01 and C*02:65.  These alleles are very rare occurring.

Affected products

A. Micro SSP Allele Specific HLA Class I DNA Typing Tray-C*02

Lot or serial number
  • 002, Batches 001-006
Model or catalog number
  • SSPR1-C02
Companies
Manufacturer

One Lambda Inc.

21001 Kittridge Street

Canoga Park

91303-2801

California

UNITED STATES