Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model...
FDA Recall #Z-0901-2025 — Class II — December 5, 2024
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
Reason for Recall
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Recalling Firm
QUIDEL ORTHO — Rochester, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4,417 units (3,358 US, 1,125 OUS)
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,
Code Information
Model No 8343386; UDI/GTIN 10758750004782; Coating 0271, expiration date; 01-March-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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated