Reported Jan 22, 2025 · Ongoing
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386…
Quidel Ortho
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: QUIDEL ORTHO · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- Brand NameVITROS
- Chemistry Products Product NameVITROS Chemistry Products
- DGXN Slides Model/Catalog Number8343386
- Software VersionNot
- Applicable Product DescriptionThe 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
- ComponentNo, not a component
- Lot codes and dates
- 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.
- Amount recalled
- 1,541 units (1,125 US, 416 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Quidel Ortho recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.