Device recall
Z-1622-2016: Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1622-2016 |
|---|---|
| Recall event | 73592 |
| Product | Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System. |
| Product code | CDQ |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 1, 2017 |
| 510(k) numbers | K051087 |
| 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