Vitros® Chemistry Products System - DGXN Slides (Digoxin)
Brand(s)
Last updated
Summary
Product
Vitros® Chemistry Products System - DGXN Slides (Digoxin)
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Vitros® Chemistry Products System - DGXN Slides (Digoxin) |
More than 10 numbers, contact manufacturer. |
834 3386 |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive, Rochester, New York, United States, 14626
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76723
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