Device recall
Z-2181-2018: Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-2181-2018 |
|---|---|
| Recall event | 80009 |
| Product | Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275. |
| Product code | LCD |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2020 |
| 510(k) numbers | K062024, K962819 |
| 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