Device recall
Z-1149-03: ABX Diagnostices Pentra 60C+ Hematology Analyzer
FDA device recall · Class III · ABX Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-1149-03 |
|---|---|
| Recall event | 26431 |
| Product | ABX Diagnostices Pentra 60C+ Hematology Analyzer |
| Product code | GKZ |
| Recalling firm | ABX Diagnostics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 17, 2014 |
| 510(k) numbers | K003677 |
| 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