Device recall
Z-0857-2015: RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal…
FDA device recall · Class II · Iris Diagnostics
Key facts
| Recall number (Z-number) | Z-0857-2015 |
|---|---|
| Recall event | 69946 |
| Product | RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood… |
| Product code | JQC |
| Recalling firm | Iris Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 2, 2015 |
| FEI number | 2023446 |
At a glance
- None 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