Ortho Vision® Analyzer
Brand(s)
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