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

70002012
70002022
70003019
70002013
70002027
70003018
70003020
70002021

6904576

Issue

During normal operation of the ortho vision analyzer, the camera imaging subsystem (CIMS) interfaces with a hardware camera to request and retrieve camera images for column grading and results interpretation. The camera software uses a first-in, first-out queuing system to take and return images to the CIMS software. Under an atypical software anomaly, images used for analysis of a test result did not come from the front and back sides of the same card. Ortho determined that the CIMS processed images out of synchronization (images captured earliest in sequence are placed at the top of the queue to be processed). As a result, image processing software utilized on the ortho vision analyzer may use mismatched front of card and back of card images for column grading and result interpretation.

Recall start date: September 22, 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
Healthcare
Recall class
Type II
Identification number
RA-72021

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