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Vitros chemistry products system - crp slides (c-reactive protein)

Official notice

9 May 2025

Last checked

9 May 2025

Medium riskHealth Canada

An official Health Canada notice concerns Vitros chemistry products system - crp slides (c-reactive protein). 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 Published 2025-05-09.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77427

Official notice

2025-05-09

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77427

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Affected products

Product 1

Affected products - Vitros Chemistry Products System - CRP Slides (C-Reactive Protein), Lot or serial number - 8812910052 8812910079 8812910019 8812910080, Model or catalog number - 809 7990

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Ortho-clinical Diagnostics, Vitros Chemistry System - Crp Slides.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

77427

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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