Health product recall

Artisan - Automated Slide Stainer, Link and Link Pro (2017-12-21)

Starting date:
December 21, 2017
Posting date:
January 8, 2018
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-65580

Affected Products

A. Artisan - Automated Slide Stainer

B. Artisan - Link

C. Artisan - Link Pro

Reason

A fume test has been conducted and set-up to measure the emission of formaldehyde from the Artisan instrument. Results for the fume test showed that the emission of formaldehyde exceeds the threshold limits set by the following provinces in Canada: Manitoba, Newfoundland & Labrador, Nova Scotia, Prince Edward Island.

Affected products

A. Artisan - Automated Slide Stainer

Lot or serial number

Not applicable

Model or catalog number

AR100

Companies
Manufacturer

Dako North America, Inc.

6392 via Real

Carpinteria

93013

UNITED STATES


B. Artisan - Link

Lot or serial number

ADL511070

ADL610220

ADL611070

ADL711120

Model or catalog number

AR210

Companies
Manufacturer

Dako North America, Inc.

6392 via Real

Carpinteria

93013

UNITED STATES


C. Artisan - Link Pro

Lot or serial number

ALPB12140

Model or catalog number

AR310

Companies
Manufacturer

Dako North America, Inc.

6392 Via Real

Carpinteria

93013

UNITED STATES