Official recall record
Vitros® Chemistry Products System - DGXN Slides (Digoxin)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-12-19
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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.
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.
Record last checked against the registry on 2026-05-31.
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