Device recall
Z-0924-2014: ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level…
FDA device recall · Class III · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Recall number (Z-number) | Z-0924-2014 |
|---|---|
| Recall event | 67133 |
| Product | ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of… |
| Product code | JJY |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 9, 2014 |
| 510(k) numbers | K110137, 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