Device recall
Z-1334-06: ABX Pentra 120,120R,120DX, automated hematology analyzer
FDA device recall · Class III · ABX Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-1334-06 |
|---|---|
| Recall event | 35719 |
| Product | ABX Pentra 120,120R,120DX, automated hematology analyzer |
| Product code | GKZ |
| Recalling firm | ABX Diagnostics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 23, 2012 |
| 510(k) numbers | K022200, K050719 |
| FEI number | 3002698356 |
At a glance
- 1–9 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