This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
LABType HD DRB1 Typing Test
- Starting date:
- January 19, 2015
- Posting date:
- March 6, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43815
Recalled products
- LABType HD DRB1 Typing Test
Reason
The following allele specificities are missing from the lot specific user documents and catalog file for the LABType HD DRB1 typing test (Catalog ID RSSOH2B1, LOT 009, Batches 1-16):
- DRB1*03:12
- DRB1*03:16
- DRB1*04:23
- DRB1*04:25
- DRB1*04:32
- DRB1*04:52
- DRB1*11:40
- DRB1*14:142
- DRB1*15:06:02
- DRB1*15:74
- DRB1*15:85
- DRB3*03:02
- DRB4*01:05
- DRB4*01:08
This may cause a mistype for DRB1*04:52. A sample with DRB1*04:52 would be typed as DRB1*04:03:01/03:03/03:05/03:07~03:08 without indicating an ambiguity with DRB1*04:52.
Affected products
A. LABType HD DRB1 Typing Test
Lot or serial number
- 009, BATCH 1-16
Model or catalog number
- RSSOH2B1
Companies
- Manufacturer
-
One Lambda Inc
21001 Kittridge Street
Canoga Park
California
UNITED STATES