Allset Gold DPB1 High Resolution SSP and DPB1 SSP Unitray 12 Tests, DPB1 SSP Unitray with Taq 12 Test (2013-12-30)

Starting date:

December 30, 2013

Posting date:

March 25, 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-38617

• 
  Reason
• 
  Affected products

Recalled Products

A. Allset Gold DPB1 High Resolution SSP

B. DPB1 SSP Unitray 12 Tests, DPB1 SSP Unitray with Taq 12 Test

Reason

There are three reactivity updates with respect to these kits:

1. In primer mix DPB004 (lane 4), the reactivity for the DPB1*31:01 has been updated from positive to negative. Prior to this update, in the presence of the DPB1*31:01 allele, users may have obtained a negative reaction leading to a no-type result.

2. In primer mix DPB027B (lane 27) and DPB039A (lane 39), the reactivity for the DPB1*88:01 allele has been updated from positive to negative. Prior to this update, in the presence of the DPB1*88:01 allele, users may have obtained a negative reaction leading to a no-type result.

3. In primer mix DPB039A (lane 39), the reactivity for the DPB1*29:01 allele has been updated from positive to negative. Prior to this update, in the presence of the DPB1*29:01 allele, users may have obtained a negative reaction leading to a no-type result.

Affected products