Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 834338
Summary
The FDA issued a Class II for Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products D by QUIDEL ORTHO. Reason: Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results..
Details
Source
Device Recall
External ID
Z-0902-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
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. Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. One sales unit contains 5 cartridges. Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit. Component: No, not a component
Lot/Code Info: Model No 8343386; UDI/GTIN 10758750004782; Coating 0272, expiration date; 01-April-2025 The scope of this recall is limited to consignees who received VITROS Chemistry Products DGXN slides in the last 18 months. This will include in-date lots manufactured from coatings (production formulation) 0271 and/or 0272. Of the in date product, the latest expiration date is listed for the coating.
Quantity Affected: 1,541 units (1,125 US, 416 OUS)
Reason for Recall
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Distribution
Domestic: Nationwide Distribution International: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom,
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-05
Company
Rochester, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
QUIDEL ORTHO has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (QUIDEL ORTHO) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does QUIDEL ORTHO have FDA actions?
QUIDEL ORTHO has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0902-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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