Drug recall
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog…
FDA recall event 95904 · Class II · QUIDEL ORTHO
Key facts
| Event ID | 95904 |
|---|---|
| Recall numbers | Z-0901-2025, Z-0902-2025 |
| Recalling firm | QUIDEL ORTHO |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results. |
| Initiation date | Dec 5, 2024 |
| Report date | Jan 22, 2025 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 3032012487 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: