Health product recall

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