LIFECODES HLA-DRB1 SSO, HLA-DQA1/B1 SSO, and HLA-DPA/B1 SSO Typing Kit (2017-07-07)
- Starting date:
- July 7, 2017
- Posting date:
- March 23, 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-66286
Affected products
- LIFECODES HLA-DRB1 SSO TYPING KIT
- LIFECODES HLA-DQA1/B1 SSO TYPING KIT
- LIFECODES HLA-DPA1/B1 SSO TYPING KIT
Reason
As a result of a complaint investigation, Immucor found that a number of its LIFECODES HLA SSO TYPING KITS were affected by an error in the MATCH IT! DNA 3.27.0 allele database update. The lot specific software files for these kits had incorrect probe assignments for some alleles which could have led to a potential mistype of certain alleles.
Affected products
A. LIFECODES HLA-DRB1 SSO TYPING KIT
Lot or serial number
- 04226A
- 11125A
Model or catalog number
628923
Companies
- Manufacturer
-
Immucor GTI Diagnostics, Inc.,
20925 Crossroads Circle,
Waukesha
53186
UNITED STATES
B. LIFECODES HLA-DQA1/B1 SSO TYPING KIT
Lot or serial number
- 06306A
- 10205A
- 3004970
Model or catalog number
628930
Companies
- Manufacturer
-
Immucor GTI Diagnostics, Inc.,
20925 Crossroads Circle,
Waukesha
53186
UNITED STATES
C. LIFECODES HLA-DPA1/B1 SSO TYPING KIT
Lot or serial number
- 12085A
- 3004756
Model or catalog number
628936
Companies
- Manufacturer
-
Immucor GTI Diagnostics, Inc.,
20925 Crossroads Circle,
Waukesha
53186
UNITED STATES