CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report

Vitros Chemistry Products Dgxn Slides recalled by Quidel Ortho

Quidel Ortho is recalling Vitros Chemistry Products Dgxn Slides, distributed nationwide in the US. The recall was initiated on 5 Dec 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled4,417 units (3,358 US, 1,125 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0901-2025
FDA event ID: 95904
Recalling firm: Quidel Ortho, Rochester, NY
Classification: Class II
Status: Ongoing
Recall initiated: 5 Dec 2024
FDA classified: 10 Jan 2025
Reported: 22 Jan 2025
Type: Voluntary: Firm initiated
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

5 Dec 2024	Recall initiated by company
10 Jan 2025	Classified by FDA	+36 days
22 Jan 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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,

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 95904

This product is part of a recall event; the main page for the event is Vitros Chemistry Products Dgxn Slides recalled by Quidel Ortho.

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025	CLASS II	Vitros Chemistry Products Dgxn Slides recalled by Quidel Ortho	Quidel Ortho	Device Malfunction	Nationwide

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Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Device	CLASS II	Vitros Chemistry Products Dgxn Slides recalled by Quidel Ortho	Quidel Ortho	Device Malfunction	Nationwide

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