Device recall
Z-0039-2017: Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0039-2017 |
|---|---|
| Recall event | 74987 |
| Product | Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB |
| Product code | CIC |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 11, 2017 |
| 510(k) numbers | K061792 |
| 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