Device recall
Z-0979-2017: SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0979-2017 |
|---|---|
| Recall event | 75837 |
| Product | SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis, Gwynedd… |
| Product code | CEW |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 25, 2018 |
| 510(k) numbers | K013566 |
| FEI number | 2432235 |
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