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Vitros chemistry products system - crp slides (c-reactive protein)
Official notice
9 May 2025
Last checked
9 May 2025
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
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
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.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
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Brand: Ortho-clinical Diagnostics, Vitros Chemistry System - Crp Slides.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
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