This page has been archived on the Web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.

Archived

This page has been archived on the Web.

Health product recall

ALLSET GOLD HIGH RES SSP UNITRAY (2015-07-08)

Starting date:
July 8, 2015
Posting date:
August 18, 2015
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-54680

Affected Products

  1. ALLSET GOLD A HIGH RES SSP
  2. A HIGH RES SSP UNITRAY 10TESTS

Reason

A customer reported that in allset+ gold a high res SSP kit, lot 012 1608823 the reactivity for lane 86 was negative for an a*03:20 allele when the labeling indicates the reactivity should be positive. Also, the High Res SSP UniTray kits are affected by this complaint since they contain the same reagents as the allset+ gold a high res SSP kits. The labeling discrepancy may lead to potentially mistyping a*03:20 allele (population frequency < 0.01%) as a*03:01.

Affected products

A. ALLSET GOLD A HIGH RES SSP

Lot or serial number
  • 012 1395079
  • 012 1446993
  • 012 1544269
  • 012 1608823
  • 012 1608903
  • 012 1615252
  • 012 1648453
Model or catalog number

54010D

Companies
Manufacturer
One Lambda Inc
21001 Kittridge Street
Canoga Park
California
UNITED STATES

B. A HIGH RES SSP UNITRAY 10TESTS
 

Lot or serial number

012 1467113
012 1580702
012 1608873

Model or catalog number

47290-10

Companies
Manufacturer
One Lambda Inc
21001 Kittridge Street
Canoga Park
California
UNITED STATES

Date modified: