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Ortho vision and vision max analyzer
Official notice
14 Jul 2023
Last checked
14 Jul 2023
An official Health Canada notice concerns Ortho vision and vision max analyzer. 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 Published 2023-07-14.
What to do now
Review notice & retain for lab, return reply form, continued use must only occur using supplied directions.
Recall number
73953
Official notice
2023-07-14
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Brand: Ortho-clinical Diagnostics, Ortho Vision And Vision Max Analyzer.
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Documents, notices & source
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