Official recall record

VITROS® Chemistry Products System - LAC Slides (Lactate)

Health Canada — Medical Devices · 2025-08-14 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2025-08-14
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

QuidelOrtho investigated customer complaints related to the inability to successfully calibrate VITROS® LAC slides on VITROS® XT 3400 systems and VITROS® XT 7600 systems. To resolve this issue, QuidelOrtho has adjusted the assay parameter used by the reflectometer to process VITROS® LAC slides. This parameter adjustment will be implemented beginning in add DRV 6339 (and above). QuidelOrtho advises affected customers to load add DRV 6339 (or above) upon receipt. Recall start date: August 5, 2025

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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