Health product recall

Autostainer, Autostainer Plus, Autostainer Plus Link, Autostainer 48 Link (2019-01-05)

Starting date:
January 5, 2019
Posting date:
May 3, 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-69844



Last updated: 2019-05-03

Affected Products

A. Autostainer

B. Autostainer Plus

C. Autostainer Plus Link

D. Autostainer 48 Link

Reason

Agilent has identified an additional correction to the risk of slide rack leveling failures as described in the current Autostainer User Guides. Such failures have the potential to impact staining quality with weak/uneven staining, which may lead to false negative test results.

Affected products

A. Autostainer

Lot or serial number

More than 10 numbers, 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

More than 10 numbers, 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

More than 10 numbers, 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

More than 10 numbers, contact manufacturer.

Model or catalog number

AS480

Companies
Manufacturer

Dako North America, Inc.

6392 via Real

Carpinteria

93013

California

UNITED STATES