Allset+T Gold HLA ABC Low Resolution (2014-03-11)

Starting date:

March 11, 2014

Posting date:

April 4, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-38683

• Reason
• Affected products

Recalled products

1. Allset+T Gold HLA ABC Low Resolution

Reason

When using 54340D Allset+ Gold HLA ABC Low Resolution kit lot number 038 1249868, Primer mix PM085C has been shown to produce a weak false positive reaction of correct size (420 base pair PCR Amplicon) in the presence of samples containing C*04 homozygote allele(s). Primer mix PM085C can be found in lane 78. As a result of the false positive reaction, samples containing two C*04 alleles could produce a mistype or no-type result depending on the reaction pattern corresponding to the full ABC HLA typing.

Affected products