Health product recall

VITROS® Systems

Last updated

Summary

Product
VITROS® Systems
Issue
Medical devices - Performance issue
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