Autostainer Link (2020-08-31)
- Starting date:
- August 31, 2020
- Posting date:
- September 25, 2020
- 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-74013
Last updated:
2020-09-25
Affected Products
- Autostainer
- Autostainer Plus
- Autostainer Plus Link
- Autostainer 48 Link
Reason
The Autostainer Link Basic User Guide has been updated in order to reduce the potential risk of false negative results in the case of leakage of buffer and/or reagents that may impact staining. The updated version of the Autostainer Link Basic User Guide (rev. 06), contains additional instructions, warnings and precautions that applies to all Autostainer instrument models (AS480, AS100, S3800 and S3400) with the aim of improving detection of possible leakage and potential staining abnormalities.
Affected products
A. Autostainer
Lot or serial number
Contact manufacturer.
Model or catalog number
S3400
Companies
- Manufacturer
-
Dako North America, Inc.
6392 via Real
Carpinteria
93013
California
UNITED STATES
B. Autostainer Plus
Lot or serial number
Contact manufacturer.
Model or catalog number
S3800
Companies
- Manufacturer
-
Dako North America, Inc.
6392 via Real
Carpinteria
93013
California
UNITED STATES
C. Autostainer Plus Link
Lot or serial number
Contact manufacturer.
Model or catalog number
AS100
Companies
- Manufacturer
-
Dako North America, Inc.
6392 via Real
Carpinteria
93013
California
UNITED STATES
D. Autostainer 48 Link
Lot or serial number
Contact manufacturer.
Model or catalog number
AS480
Companies
- Manufacturer
-
Dako North America, Inc.
6392 via Real
Carpinteria
93013
California
UNITED STATES