Allset Gold and SSP Unitary Low Resolution Kits (2013-08-30)

Starting date:

August 30, 2013

Posting date:

November 29, 2013

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-36891

• 
  Reason
• 
  Affected products

Recalled Products

A. Allset Gold HLA Low Resolution Kits

B. Allset Gold ABC Low Resolution Kit

C. Allset Gold ABDRQ Low Resolution Kit

D. SSP Unitary - Low Resolution Class I

Reason

During an internal complaint investigation for problem report PR#135598, the reactivity assignment in our Human Oligotyping software (HOS) program for A32:04 allele in primer mix PM019e was determined to be incorrect. The catalog and lot numbers of the products listed above have been identified to be affected by the incorrect reactivity assignment. The kits would produce an incorrect low resolution typing or mistyping result of A*02, A*03 alleles when testing a sample which has the A*32:04 allele. The user would be unaware of the incorrect type, unless they confirm the sample typing by another method, therefore, this would be considered a mistype.

Affected products