Health product recall

Ortho Optix™ Reader

Last updated

Summary

Product
Ortho Optix™ Reader
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or Serial Number Model or catalog number
Ortho Optix™ Reader Not applicable. 6842222

Issue

Ortho Clinical Diagnostics received a complaint regarding an incorrectly displayed passing QC status for a test (see example in table below), without the site having processed the multiple QC kits configured for the test. Ortho confirmed that any test processed with multiple QC kits may encounter this issue. If one QC kit out of the multiple QC kits configured for the test has successfully passed, the software will automatically assign a passing QC status to the test even if the other QC kit configured for the test is not run or does not pass.

Recall start date: Apr 11, 2022

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
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64093

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