Health product recall

Ortho Vision Analyzers

Last updated

Summary

Product
Ortho Vision Analyzers
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 catalogue number

Ortho Vision Analyzer

More than 10 numbers, contact manufacturer.

6904577

Ortho Vision Max Analyzer

More than 10 numbers, contact manufacturer.

6904576

Issue

Due to a wash protocol implementation discrepancy, there is potential for carry over of the Anti-S which may impact results of certain tests after pipetting Anti-S reagent. This issue is intermittent because several factors must interact across a series of events for the false positive to occur. The wash protocol will be updated in the next software release.

Recall start date: March 21, 2024

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-75367

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