Device recall
Z-2241-2016: Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No…
FDA device recall · Class II · CSL Behring GmbH
Key facts
| Recall number (Z-number) | Z-2241-2016 |
|---|---|
| Recall event | 74468 |
| Product | Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System. |
| Product code | LPS |
| Recalling firm | CSL Behring GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2018 |
| 510(k) numbers | K063206 |
| FEI number | 3003098680 |
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