Help us improve our website

Health product recall

Ortho Vision Analyzers

Last updated


Ortho Vision Analyzers
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.


Affected products

Affected products

Lot or serial number

Model or catalog number

Ortho Vision Analyzer

More than 10 numbers, contact manufacturer.


Ortho Vision Max Analyzer

More than 10 numbers, contact manufacturer.



Ortho's investigation discovered that the self-service customer procedures guide, both onboard and offboard, contains 2 errors related to the probe installation/removal process (chapter 4).

1. The self-service customer procedure guide contains a note indicating the probe can be replaced without using the software maintenance task. If it is performed this way, the instructions do not instruct the operator to condition the probe (daily maintenance) after replacement, which is a required post requisite activity.

2. The self-service customer procedure guide contains a note indicating the software will initiate the pump test, after probe replacement is complete. This is incorrect, since upon completion of the probe replacement maintenance task, the software marks the pipetting volume test as pending rather than the pump test.
Note: if the user follows the software's on-screen instructions, daily maintenance is automatically performed during the probe replacement task and the operator is notified of the pending pipetting volume test, which if completed, mitigates this issue.

To date, no customer complaints have been recorded regarding this issue.

Recall start date: December 21, 2022

Additional information

Original published date: 2023-01-04
Alert / recall type
Health product recall
Health products - Medical devices - Haematology

Ortho-Clinical Diagnostics Inc.

1001 Us Hwy 202, Raritan, New Jersey, United States, 08869

Published by
Health Canada
Recall class
Type II
Identification number