Device recall
Z-2117-2020: ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are…
FDA device recall · Class II · Abbott Gmbh & Co. KG
Key facts
| Recall number (Z-number) | Z-2117-2020 |
|---|---|
| Recall event | 85590 |
| Product | ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy. |
| Product code | LCD |
| Recalling firm | Abbott Gmbh & Co. KG |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K102699 |
| FEI number | 3002809144 |
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