Autostainer & Autostainer Plus (2019-11-01)
- Starting date:
- November 1, 2019
- Posting date:
- November 29, 2019
- 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-71722
Last updated: 2019-12-02
Affected Products
A. Autostainer
B. Autostainer Plus
Reason
Some autostainer customers potentially lack installation of an autostainer syringe tray. The field safety notice is to ensure that all autostainer instruments have a syringe tray installed. For instruments without a syringe tray, there is a remote possibility that the stopcock, syringe pump or the assembly of these items may drip, resulting in a small volume of excess buffer being applied to one or two slide(s) loaded in rack 3.
Affected products
A. Autostainer
Lot or serial number
DC3400-6901-03
DC3400-6724-03
DC3400-6778-03
DC3400-6936-03
DC3400-6955-03
DC3400-6975-03
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
AS1187F1007
AS1207F1009
Model or catalog number
S3800
Companies
- Manufacturer
-
Dako North America, Inc.
6392 via Real
Carpinteria
93013
California
UNITED STATES