Health product recall

Ortho Vision® Analyzer

Last updated

Summary

Product
Ortho-Clinical Diagnostics Inc.
Issue
Medical devices - Quality issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Ortho Vision® Analyzer

Not applicable.

6904576

Ortho Vision® Max Analyzer

Not applicable.

6904576

Issue

Ortho Clinical Diagnostics received complaints in which customers obtained unexpected results on their Ortho Vision Analyzer. upon further investigation, Ortho confirmed that incorrect utilization of the "assign to position" feature by physically placing the sample(s) in a different location than was manually assigned caused the misidentification of a sample.

Recall start date: Apr 18, 2022

Additional information

Details
Original published date: 2022-05-04
Alert / recall type
Health product recall
Category
Health product - Medical device - 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-64136