This page has been archived on the Web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.

Health product recall

BENCHMARK ULTRA AUTOMATED IMMUNOSTAINING SYSTEM (2015-11-26)

Starting date:
November 26, 2015
Posting date:
January 7, 2016
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-56516

Affected Products

A. BENCHMARK ULTRA AUTOMATED IMMUNOSTAINING SYSTEM

Reason

This recall is related to a potential issue with the BenchMark ULTRA VSS software version 11.9 up to and including 12.3 regarding issues with the keycodes when reprinting labels.

Affected products

A. BENCHMARK ULTRA AUTOMATED IMMUNOSTAINING SYSTEM

Lot or serial number

Versions 11.9 to 12.3

Model or catalog number

N750-BMKU-FS

Companies
Manufacturer
Ventana Medical Systems Inc.
1910 E Innovation Park Drive,
Tucson
85755
Arizona
UNITED STATES