Device recall
Z-1146-2014: ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA…
FDA device recall · Class II · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Recall number (Z-number) | Z-1146-2014 |
|---|---|
| Recall event | 67332 |
| Product | ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and… |
| Product code | JIX |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 5, 2014 |
| 510(k) numbers | K110530 |
| FEI number | 3002698356 |
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