Recall MonitorHealth Products
Vitros Chemistry Products System - CRP Slides (C-Reactive Protein)
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Immunology
Product: Vitros Chemistry Products System - CRP Slides (C-Reactive Protein)
Issue: Medical devices - Labelling and packaging
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare, Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Vitros Chemistry Products System - CRP Slides (C-Reactive Protein) | 8812910052 8812910079 8812910019 8812910080 | 809 7990 |
Issue
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