Digoxin Test Slides May Report Inaccurately Due to Hemoglobin Interference
QUIDEL ORTHO is recalling VITROS DGXN test slides because hemoglobin can interfere with digoxin measurements at lower-than-expected levels, potentially causing inaccurate test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product where injury has not yet been reported. The measurement error with digoxin, a critical cardiac medication, could lead to incorrect dosing decisions. No actual illnesses or injuries are documented in the source, limiting the score to at most 3 per the rubric.
Plain-English summary
QUIDEL ORTHO has recalled VITROS Chemistry Products DGXN Slides (Model 8343386), analytical test elements used to measure digoxin concentration in blood serum. Digoxin is a cardiac medication used to treat congestive heart failure and abnormal heart rhythms. These slides work with VITROS Chemistry Systems including the 250/350/5.1 FS/4600/XT 3400 and 5600/XT 7600 models.
The recall affects 4,417 units (3,358 in the United States and 1,125 internationally) distributed nationwide and to multiple countries including Canada, Australia, the United Kingdom, Belgium, Brazil, Germany, Japan, and others. The affected products are those manufactured in the past 18 months with coating formulations 0271 and/or 0272 that remain in stock (expiration date on or after March 1, 2025).
The issue is that hemoglobin in patient samples can interfere with the digoxin measurement at concentrations lower than the originally claimed limit of 300 mg/dL. When this interference occurs, the test produces negatively biased results—meaning the measured digoxin level is lower than the actual level in the patient's blood.
The recalled product
- Product
- Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxi
- Manufacturer
- QUIDEL ORTHO
- Hazard
- measurement-error
- hemoglobin-interference
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model No 8343386
- UDI/GTIN 10758750004782
- Coating 0271
- expiration date
- the latest expiration date is listed for the coating.
Distribution
Distributed nationwide across the United States.
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