Device recall
Z-0827-2010: RambaChrom KPC M/N 11500. RambaCHROM KPC is for detection of gram negative…
FDA device recall · Class II · Gibson Laboratories Inc
Key facts
| Recall number (Z-number) | Z-0827-2010 |
|---|---|
| Recall event | 54184 |
| Product | RambaChrom KPC M/N 11500. RambaCHROM KPC is for detection of gram negative bacteria with a reduced susceptibility to most of the carbapenem agents. |
| Product code | JSO |
| Recalling firm | Gibson Laboratories Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 21, 2012 |
| FEI number | 1050138 |
At a glance
- None 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