Official recall record

VITROS® Systems (ref 74504)

Health Canada — Medical Devices · 2023-10-31 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2023-10-31
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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