Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 22, 2025
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
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Quidel Ortho recalled Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slide… - a moderate-severity action.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slide… was recalled by Quidel Ortho in January 22, 2025. Reason: Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negativel…. Check the official notice for the remedy. Verify recall #Z-0902-2025 with the FDA Devices before acting.
The recall
Quidel Ortho issued this moderate-severity FDA Devices recall-Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negativel….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- January 22, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0902-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0902-2025) was formally reported on January 22, 2025, with the manufacturer initiating the action on December 5, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Quidel Ortho is listed as the recalling firm, operating out of Rochester, NY. Federal records list the affected scope as 1,541 units (1,125 US, 416 OUS).
The documented reason for this recall is: Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results. Distribution data in the federal record shows the product reached: Domestic: Nationwide Distribution International: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singap…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,541 units (1,125 US, 416 OUS)
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0902-2025 |
| Date reported | January 22, 2025 |
| Date initiated | December 5, 2024 |
| Recalling firm | Quidel Ortho |
| Firm location | Rochester, NY |
| Affected scope | 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, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0902-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Quidel Ortho. Units affected: 1,541 units (1,125 US, 416 OUS).
Why was this product recalled? ▼
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0902-2025.
Where was the recalled product distributed? ▼
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,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0902-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 22, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.