# FDA recall Z-0902-2025

> **QUIDEL ORTHO** · Class II · device recall initiated 2024-12-05.

## 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.      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.

## 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,

## Key facts

- **Recall number:** Z-0902-2025
- **Recalling firm:** QUIDEL ORTHO
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-05
- **Report date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0902-2025

## Citation

> AI Analytics. FDA recall Z-0902-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0902-2025. Source: US FDA. Licensed CC0.

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