Device recall
Z-1173-2014: Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A…
FDA device recall · Class II · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Recall number (Z-number) | Z-1173-2014 |
|---|---|
| Recall event | 67528 |
| Product | Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers. |
| Product code | JQP |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2014 |
| 510(k) numbers | K053308 |
| 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