This page has been archived on the Web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.
Autostainer various models (2015-02-23)
- Starting date:
- February 23, 2015
- Posting date:
- March 20, 2015
- 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-52619
Recalled Products
A) Autostainer
B) Autostainer Plus
C) Autostainer Plus Link
D) Autostainer Link 48
Reason
Defective stopcock component of syringe assembly may leak excess buffer. Excess buffer may dilute reagent on slide and cause false negative result.
Affected products
A) Autostainer
Lot or serial number
AS1474D0910
AS1766D1010
AS2040D1106
AS2041D1106
AS2042D1106
AS2044D1106
AS48-0204-01
AS48-0363-01
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
All lots.
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
All lots.
Model or catalog number
AS100
Companies
- Manufacturer
-
Dako North America, Inc.
6392 via Real
Carpinteria
93013
California
UNITED STATES
D) Autostainer Link 48
Lot or serial number
All lots.
Model or catalog number
AS480
Companies
- Manufacturer
-
Dako North America, Inc.
6392 via Real
Carpinteria
93013
California
UNITED STATES