Device recall
Z-1914-2019: Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1914-2019 |
|---|---|
| Recall event | 82980 |
| Product | Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on… |
| Product code | CGS |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 19, 2021 |
| 510(k) numbers | K160724 |
| FEI number | 2517506 |
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