Device recall
Z-0212-2015: IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000…
FDA device recall · Class III · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0212-2015 |
|---|---|
| Recall event | 69588 |
| Product | IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE Systems Analyzers for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treatment… |
| Product code | JJY |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 31, 2017 |
| 510(k) numbers | K023304 |
| 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