Health product recall

VITROS® Systems

Last updated

Summary

Product
VITROS® Systems
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 catalog number

VITROS® 3600 Immunodiagnostic System-Instrument

Software Version 3.8.0 and 3.8

680 2914
680 2783

VITROS® XT 7600 Integrated System

Software Version 3.8.0 and 3.8

684 4461

VITROS® 4600 Chemistry System - Hardware

Software Version 3.8.0 and 3.8

680 2445
690 0440

VITROS® 4600 Chemistry System - Refurbished Hardware

Software Version 3.8.0 and 3.8

690 0440

VITROS® 5600 Integrated System

Software Version 3.8.0 and 3.8

680 2413
680 2915

VITROS® XT 3400 Chemistry System

Software Version 3.8.0 and 3.8

684 4458

Issue

Issue #1 - QC baseline statistics are not updating as expected. This only affects VITROS® Systems running VITROS® system software version 3.8.1. 

Issue #2 - Configurable westgard rules are not being applied as expected. This affects VITROS® Systems running VITROS® System software versions 3.8.0 and 3.8.1.

Recall start date: January 31, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Ortho-Clinical Diagnostics Inc.

100 Indigo Creek Drive, Rochester, New York, United States, 14626

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75059

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