Health product recall

VITROS® Systems

Last updated

Summary

Product
VITROS® Systems
Issue
Medical devices - Performance issue
What to do

Review notice, save/post notice by each system until issues resolved, complete/return response form. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

VITROS® 5600 Integrated System (New & Refurbished)

More than 10 numbers, contact manufacturer.

680 2413
680 2915

VITROS® 3600 Immunodiagnostic System (New & Refurbished)

More than 10 numbers, contact manufacturer.

680 2914
680 2783

VITROS® 4600 Chemistry System (New & Refurbished)

More than 10 numbers, contact manufacturer.

6900440
680 2445

VITROS® XT 3400 Chemistry System

More than 10 numbers, contact manufacturer.

684 4458

VITROS® XT 7600 Integrated System

More than 10 numbers, contact manufacturer.

684 4461

VITROS® 4600 Chemistry System (New & Refurbished)

More than 10 numbers, contact manufacturer.

6802445
690 0440

Issue

After the launch of software version (v) 3.8.0, Ortho Clinical Diagnostics (QuidelOrtho) began post-release monitoring of the rollout of v3.8.0. this monitoring has led QuidelOrtho to confirm that if v3.8.0 has been installed on the VITROS® systems listed above, these systems may experience an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a 'screen freeze'), and/or printer disconnections.

Recall start date: October 11, 2023

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-74504

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