VITROS DGXN Slides Recalled Due to Hemoglobin Interference in Digoxin Measurement
VITROS DGXN Slides are recalled because hemoglobin can interfere with digoxin measurement, producing artificially low results. Approximately 1,541 units were distributed in the US and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 Class II device recall with no reported illnesses or injuries, but it involves a measurement accuracy issue with digoxin—a narrow-therapeutic-index cardiac medication where even small errors in serum level measurement can affect clinical dosing decisions. It qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
QUIDEL ORTHO has recalled VITROS Chemistry Products DGXN Slides (Model 8343386), diagnostic test slides used to measure digoxin concentration in patient blood serum. The recall was initiated because hemoglobin interference may occur at concentrations lower than the claimed maximum threshold of 300 mg/dL, which can cause the test to produce artificially low (negatively biased) digoxin measurement results.
The recall affects 1,541 distributed units: 1,125 in the United States (nationwide distribution) and 416 distributed internationally to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and the United Kingdom. The affected product includes in-date lots manufactured with coating formulations 0271 and/or 0272, with the latest expiration date of April 1, 2025. The recall scope includes consignees who received product within the last 18 months.
Digoxin is a cardiac medication used to treat congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient therapy compliance and to diagnose potential overdose. The accuracy of these test measurements is essential for proper clinical management of patients receiving digoxin therapy.
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.…
- Manufacturer
- QUIDEL ORTHO
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 0272
- expiration date
- the latest expiration date is listed for the coating.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by QUIDEL ORTHO under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · QUIDEL ORTHO
See all →- HighDigoxin Test Slides May Report Inaccurately Due to Hemoglobin Interference
FDA (Devices) · 2025-01-22
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