Official recall record

Vitros Chemistry Products System - CRP Slides (C-Reactive Protein)

Health Canada — Medical Devices · 2025-05-09 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2025-05-09
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

During our internal testing, QuidelOrtho determined that coating 1291 was incorrectly assigned GEN 88, instead of the intended GEN 83. Product labeling for all lots manufactured from coating 1291 lists the generation as GEN 88, including the product carton, foil wrapper, and cartridge (cart) label. The cart label is scanned by the Vitros® System to determine the GEN of the product. The GEN is associated with specific calibration parameters, which are stored on assay data disks and calibration diskettes and used by Vitros systems to process Vitros slides. Recall Start Date: April 25, 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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