Z-0901-2025Class II

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog...

Name: Z-0901-2025 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog...
Creator: Quidel Ortho
Published: 2024-12-05
License: https://open.fda.gov/license/

Quidel Ortho / initiated 2024-12-05 / Open, Classified / root cause: design

FDA source

QUIDEL ORTHO began a recall of Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable... on 2024-12-05. FDA classified it as Class II and gives the reason as "Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0901-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-05
Posted: 2025-01-10
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
Product code: LFM Enzyme Immunoassay, Digitoxin
Reason for recall: Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Root cause tag: design
FDA 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 in commerce: 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,
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0901-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0901-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10
Z-0902-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10

Product code LFM

K942610Class IIKodak Extachem Clinical Chemistry Slide Digoxin (Dgxn)Eastman Kodak Company / cleared 1994-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)