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