Device recall
Z-2073-2025: VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS…
FDA device recall · Class II · Ortho-Clinical Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-2073-2025 |
|---|---|
| Recall event | 97034 |
| Product | VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests. |
| Product code | DJG |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K062460 |
| FEI number | 1000136573 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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