Health product recall

Ortho Vision and Vision Max Analyzer

Last updated


Ortho Vision and Vision Max Analyzer
Medical devices - Performance issue
What to do

Review notice & retain for lab, return reply form, continued use must only occur using supplied directions. 


Affected products

Affected products

Lot or serial number

Model or catalog number

Ortho Vision Analyzer

Software 5.14.5 and below


Ortho Vision Max Analyzer

Software 5.14.5 and below



Ortho Clinical Diagnostics (QuidelOrtho™) identified a trend regarding false positive results for specific tests (listed below) processed after Ortho Sera Anti-Jkb Tests, on the ID-MTS™ buffered gel cards when tested on the Ortho Vision Analyzer. It is important to note that this issue is intermittent because several factors must interact across a series of events for a false positive test result due to ortho sera antijkb carryover to occur.

• One of the five tests listed below must be performed on the Ortho Vision/ Vision Max Analyzer in conjunction with or after the Ortho Sera Anti-Jkb testing, and

• Ortho Sera Anti-Jkb must be pipetted one or two steps before a sample or reagent in one of the tests listed below, and

• The red blood cells in the test pipetted after Ortho Sera Anti-Jkb must express the Jkb antigen. The likelihood of occurrence is higher with red cells with higher antigen expression, and

• The intermittent occurrence of Ortho Sera Anti-Jkb carryover is also dependent on several factors specific to pipetting operations on the Ortho Vision/Vision Max Analyzer such as the volume of reagents and samples pipetted, and the amount of time they are retained in the probe between aspiration and dispense which are determined by the analyzer processing steps.

Recall start date: June 28, 2023

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
Recall class
Type II
Identification number

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