Device recall
Z-0902-2025: Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products…
FDA device recall · Class II · QUIDEL ORTHO
Key facts
| Recall number (Z-number) | Z-0902-2025 |
|---|---|
| Recall event | 95904 |
| 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… |
| Product code | LFM |
| Recalling firm | QUIDEL ORTHO |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K942610 |
| FEI number | 3032012487 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database