Health product recall

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

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

A. LIFECODES HLA-B SSO Typing Kit

Lot or serial number
  • 01117A
  • 06036A
Model or catalog number

628915

Companies
Manufacturer

Immucor GTI Diagnostics, Inc.,

20925 Crossroads Circle,

Waukesha

53186

UNITED STATES

B. LIFECODES HLA-B ERES SSO Typing Kit

Lot or serial number
  • 01117B
  • 06036B
Model or catalog number

628917

Companies
Manufacturer

Immucor GTI Diagnostics, Inc.,

20925 Crossroads Circle,

Waukesha

53186

UNITED STATES