Health product recall

Ortho Optix Reader

Last updated

Summary

Product
Ortho Optix Reader
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Ortho Optix Reader

More than 10 numbers, contact manufacturer.

6842222

Issue

There is an issue where mixed field (MF) grade error codes may not be generated on the Ortho Optix™ Reader as required by the software.

Recall Start Date: January 31, 2025

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies

Ortho-Clinical Diagnostics Inc.

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

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76945

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