QUIDEL ORTHO: 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

Recall number

Z-0902-2025

Recalling firm

QUIDEL ORTHO

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

Status

Open, Classified

Initiated

2024-12-05

Posted

2025-01-10

Terminated

not on file

Reason

Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.

Root cause

Device Design

Action

On December 5, 2024 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to consignees. REQUIRED ACTIONS - For customers who have VITROS 5,1 FS/4600/5600/XT 3400/XT 7600 Systems: Load ADD DRV 6308 upon receipt. - For customers who have VITROS 250/350 Systems: Please be aware of the lowering of the Interferent Concentration limit from 300 mg/dL to 100 mg/dL at a digoxin concentration of 2.0 ng/mL (2.6 nmol/L). - Complete and return the enclosed Confirmation of Receipt form no later than December 13, 2024. - Save this notification with your User Documentation or post this notification by each VITROS 250/350/5,1 FS/4600/5600/XT 3400/XT 7600 System in your laboratory until the issue has been resolved. - Please forward this notification if the affected product was distributed outside of your facility. - If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization. Resolution Our investigation to revise the limit at which hemoglobin interference may reach an unacceptable level is ongoing. In the interim we will be issuing a Technical Bulletin to implement the temporary changes to the Sample Indices Threshold default hemolysis limit on the ADD and the hemoglobin Interferent Concentration limit for digoxin listed in the IFU. We will communicate again after our investigation has completed. QuidelOrtho is targeting to have an update by Q1 2025. Contact Information We apologize for the inconvenience this may cause your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-421-3311. To report adverse events, contact your local Global Services Organization. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm, 1-800-332-1088. On December 5, 2024 URGENT PRODUCT CORRECTION NOTIFICATION lette

Quantity

1,541 units (1,125 US, 416 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,

Lot, serial or model codes

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.

510(k) numbers

["K942610"]

PMA numbers

not on file

Product code

LFM

Firm FEI

3032012487

Firm city

Rochester

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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