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Health Canada Medical devices

Vitros® Chemistry Products System - DGXN Slides (Digoxin)

Issued December 19, 2024
Issue
QuidelOrtho has confirmed an issue involving Vitros® Chemistry Products DGXN Slides which may generate negatively biased results due to hemoglobin interference at a concentration lower than what is currently listed in the instructions for use (ifu) at 300 mg/dl (3 g/l). Recall start date: December 10, 2023.
Hazard description
Labelling and packaging
Product
Product name
Vitros® Chemistry Products System - DGXN Slides (Digoxin)
Reference
ID
RA-76723