Device recall
Z-1815-2025: Apo B Reagent, REF: OSR6143
FDA device recall · Class III · Beckman Coulter Ireland, Inc.
Key facts
| Recall number (Z-number) | Z-1815-2025 |
|---|---|
| Recall event | 96746 |
| Product | Apo B Reagent, REF: OSR6143 |
| Product code | JHN |
| Recalling firm | Beckman Coulter Ireland, Inc. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K952466 |
| FEI number | 1000206808 |
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