Health product recall

Ortho Optix™ Reader

Last updated


Ortho Optix™ Reader
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 catalogue number
Ortho Optix™ Reader More than 10 numbers, contact manufacturer. 6842222


On the Ortho Optix Reader, when reviewing the results, the user can edit a grade and/or analysis of the results.
• When performing this action, the user may also choose to "cancel" the edit.
•Wwhen cancelling the edit, the user is informed that the "changes have not been saved" via a user interface prompt, which the user must "acknowledge/accept".
• After the user "accepts", the result displayed on the user interface reverts as expected back to the original result and awaits result approval.
• However, when the user completes "result approval", the result that is unexpectedly stored in the database and reported out of the system (such as to a connected lis) is the "edited result" that was previously cancelled.
When this anomaly occurs, there is potential for an erroneous result to be stored in the database and reported out of the system.

Recall start date: August 12, 2022

Additional information

Original published date:
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
General public
Recall class
Type II
Identification number

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