Device recall
Z-1030-2016: Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1030-2016 |
|---|---|
| Recall event | 73080 |
| Product | Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine… |
| Product code | JZG |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 13, 2017 |
| 510(k) numbers | K083463 |
| 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