LIFECODES HLA-B SSO and HLA-B ERES SSO Typing Kit (2018-03-15)

Starting date:

March 15, 2018

Posting date:

June 22, 2018

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-67092

• 
  Reason
• 
  Affected products

Affected products

A. LIFECODES HLA-B SSO Typing Kit

B. LIFECODES HLA-B ERES SSO Typing Kit

Reason

As a result of a complaint investigation, Immucor GTI Diagnostics, Inc. has determined the serological group for the B*27:08 allele was incorrectly assigned as BW4. The correct serological group assignment for B*27:08 is BW6. This assignment was part of the 3.29.0 allele database update.

Affected products