Device recall
Z-1553-2016: ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete…
FDA device recall · Class II · Horiba Instruments Inc
Key facts
| Recall number (Z-number) | Z-1553-2016 |
|---|---|
| Recall event | 73349 |
| Product | ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity… |
| Product code | JJE |
| Recalling firm | Horiba Instruments Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 17, 2016 |
| FEI number | 3002698356 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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