Device recall
Z-0665-2013: Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R)…
FDA device recall · Class III · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0665-2013 |
|---|---|
| Recall event | 63941 |
| Product | Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum. |
| Product code | DKB |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 24, 2013 |
| 510(k) numbers | K790735 |
| FEI number | 2517506 |
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